- Trials with a EudraCT protocol (680)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (126)

These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006). | |
Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records. |
Study title: |
Active substance: Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine (adsorbed, reduced antigen(s) content) |
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Document reference: 47296 |
Study title: Open, controlled, randomized phase III clinical study to assess the immunogenicity and reactogenicity of TdcP-IPV vaccine vs DTacP + OPV in 6 years old children previously immunized with 4 doses of DTwcP and OPV from 2 months of age. |
Active substance: Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine (adsorbed, reduced antigen(s) content) |
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Document reference: 47295 |
Study title: Safety and Immunogenicity of Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis (TdcP) Vaccine Compared to Tetanus and Diphtheria Toxoids Adsorbed (Td) in Adolescents and Adults 11-64 Years of Age |
Active substance: Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine (adsorbed, reduced antigen(s) content) |
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Document reference: 47291 |
Study title: Safety and Immunogenicity of Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis (TdcP) Vaccine Compared to Tetanus and Diphtheria Toxoids Adsorbed (Td) in Adolescents and Adults 11-64 Years of Age |
Active substance: Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine (adsorbed, reduced antigen(s) content) |
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Document reference: 47292 |
Study title: Safety and Immunogenicity of Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis (TdcP) Vaccine Compared to Tetanus and Diphtheria Toxoids Adsorbed (Td) in Adolescents and Adults 11-64 Years of Age |
Active substance: Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine (adsorbed, reduced antigen(s) content) |
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Document reference: 47293 |
Study title: Safety of four acellular pertussis combination vaccines (Infantrix-IPV, Boostrix, Covaxis and repevax) given a booster dose to six-year-old Finnish children |
Active substance: Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine (adsorbed, reduced antigen(s) content) |
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Document reference: 47294 |
Study title: Pulmonary embolism: A fatal complication of arterial chemoembolization for advanced hepatocellular carcinoma. |
Active substance: Ethyl esters of iodized fatty acids of poppy seed oil |
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Document reference: 39907 |
Study title: Successful left hepatectomy for hepatocellular carcinoma in a child after transcatheter arterial chemoembolization: Report of a survival. |
Active substance: Ethyl esters of iodized fatty acids of poppy seed oil |
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Document reference: 39945 |
Study title: The role and limitation of living donor liver transplantation for hepatocellular carcinoma. |
Active substance: Ethyl esters of iodized fatty acids of poppy seed oil |
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Document reference: 39896 |
Study title: A case of postoperative recurrence of fibrolamellar hepatocellular carcinoma with increased vitamin B(12) binding capacity in a young Japanese female. |
Active substance: Ethyl esters of iodized fatty acids of poppy seed oil |
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Document reference: 39909 |
Study title: Adjuvant intra-arterial iodine-131-labelled lipiodol for resectable hepatocellular carcinoma: A prospective randomised trial. |
Active substance: Ethyl esters of iodized fatty acids of poppy seed oil |
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Document reference: 39927 |
Study title: Hepatocellular carcinoma after transcatheter hepatic arterial embolization: A histopathologic study of 84 resected cases. |
Active substance: Ethyl esters of iodized fatty acids of poppy seed oil |
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Document reference: 39940 |
Study title: Hepatocellular carcinoma and portal vein invasion: Results of treatment with transcatheter oily chemoembolization. |
Active substance: Ethyl esters of iodized fatty acids of poppy seed oil |
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Document reference: 39935 |
Study title: Hepatocellular carcinoma outcomes based on indicated treatment strategy. |
Active substance: Ethyl esters of iodized fatty acids of poppy seed oil |
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Document reference: 39931 |
Study title: An open, controlled, randomised, clinical study to assess the immunogenicity and safety of HEXAVAC® administered to healthy infants who received hepatitis B vaccine (RECOMBIVAX H-B®) at birth |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliomyelitis Vaccine, Adsorbed and Haemophilus influenzae type b conjugate vaccine |
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Document reference: 47189 |
Study title: Assessment of the Immunogenicity and Safety of the Sanofi Pasteur DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™), Administered at 6, 10, and 14 Weeks of Age and Followed by a Booster Dose at 18-19 Months of Age in Healthy Infants Included in Two Study Groups Receiving the Hepatitis B Monovalent Vaccine Either at 0, 6, and 14 Weeks of Age or at 6, 10, and 14 Weeks of Age. |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliomyelitis Vaccine, Adsorbed and Haemophilus influenzae type b conjugate vaccine |
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Document reference: 47187 |
Study title: Clinical Safety study of the DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) in Healthy Children and in Healthy Infants in the People’s Republic of China |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliomyelitis Vaccine, Adsorbed and Haemophilus influenzae type b conjugate vaccine |
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Document reference: 41322 |
Study title: Immunogenicity and Safety of a Booster Dose of Aventis Pasteur’s DTacPIPV// PRP~T Combined Vaccine (Pentavac™/Pentaxim™) in 18-24 Months Old Children Primed with DTacP-HB-IPV-PRP~T Combined Vaccine (Hexavac™) in the Study A3R31 |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliomyelitis Vaccine, Adsorbed and Haemophilus influenzae type b conjugate vaccine |
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Document reference: 47188 |
Study 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 Dose at 18-19 Months of Age in Healthy Infants in India |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliomyelitis Vaccine, Adsorbed and Haemophilus influenzae type b conjugate vaccine |
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Document reference: 41321 |
Study title: Placebo controlled randomized study of haemophilus influenzae type b capsular polysaccharide tetanus conjugate vaccine (PRP-T) associated or combined with diphtheria- tetanus- pertussis vaccine (DTP) in two month old infants |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliomyelitis Vaccine, Adsorbed and Haemophilus influenzae type b conjugate vaccine |
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Document reference: 47153 |
Study title: Comparative Safety and lmmunogenicity Study of Diphtheria, Tetanus, Acellular Pertussis, Poliomyelitis Vaccine (DTacP-IPV) and Diphtheria, Tetanus, Whole-cell Pertussis, Poliomyelitis Vaccine (TETRACOQ) Given As a Second Booster to 4- to 7-Year-Old Children |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and inactivated Poliomyelitis Vaccine, adsorbed. |
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Document reference: 41420 |
Study title: Comparative Safety and lmmunogenicity Study of Diphtheria,Tetanus, Acellular Pertussis, Poliomyelitis vaccine (DTacP-IPV) and Diphtheria, Tetanus, Poliomyelitis Vaccine (D.T. Polio) Administered as a Booster in Children Aged 8 to 12 years |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and inactivated Poliomyelitis Vaccine, adsorbed. |
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Document reference: 41421 |
Study title: Comparative study of acellular and whole cell pertussis vaccines combined with diphtheria, tetanus and inactivated poliomyelitis type 1, 2, 3 vaccines in healthy infants (primary-immunisation and booster) |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and inactivated Poliomyelitis Vaccine, adsorbed. |
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Document reference: 41413 |
Study title: Comparative study of the safety and immunogenicity of a Diphtheria Tetanus Acellular Pertussis and a Diphtheria Tetanus Whole Cell Pertussis vaccine in Senegalese infants |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and inactivated Poliomyelitis Vaccine, adsorbed. |
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Document reference: 41411 |
Study title: Comparative, randomised, double-blind safety and immunogenicity study of the Mérieux two-component acellular pertussis vaccine and the Mérieux one-component vaccine in healthy adult volunteers |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and inactivated Poliomyelitis Vaccine, adsorbed. |
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Document reference: 41406 |
Study title: Dose response study of a Diphtheria, Tetanus, acellular Pertussis (DTacP) vaccine in 3-month-old children |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and inactivated Poliomyelitis Vaccine, adsorbed. |
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Document reference: 41407 |
Study title: Evaluation of the PMSV. Diphtheria, Tetanus, Acellular Pertussis Vaccine (DTacP) in Infants, during a NlAlD Multicenter Acellular Pertussis Trial. Comparative Study Between PMSV. DTacP and Two Conventional Whole Cell DTP Vaccines |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and inactivated Poliomyelitis Vaccine, adsorbed. |
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Document reference: 41409 |
Study title: Immunogenicity and reactogenicity of two dosages of acellular pertussis vaccine compared with whole-cell pertussis vaccine at primary (2, 4 and 6 months of age) and booster (15-24 months and 4-6 years of age) immunisation |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and inactivated Poliomyelitis Vaccine, adsorbed. |
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Document reference: 41408 |
Study title: Large Scale Safety Study of the DTacP-IPV (Acellular Tetracoq) Vaccine, Administered in Combination (one injection site) or in Association (two injection sites) with Haemophilus influenzae type b Vaccine (Act-HIB) for Primary and Booster immunisation. |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and inactivated Poliomyelitis Vaccine, adsorbed. |
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Document reference: 41415 |
Study title: Open, Randomised, Comparative Trial of the lmmunogenicity and Safety of two Immunisation Schedules (2-34 months and 24-6 months of age) using Diphtheria, Tetanus, Acellular Pertussis, Polio (DTacP-IPV) Vaccine mixed with Haemophilus influenzae type b (Act-HI B) Vaccine. |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and inactivated Poliomyelitis Vaccine, adsorbed. |
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Document reference: 41417 |
Study title: Randomised Double-Blind Study of the Relative Efficacy and Safety of a DT Acellular Pertussis Vaccine with Respect to a DTP Whole-Cell Vaccine Among Children of Rural Senegal (Niakhar) |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and inactivated Poliomyelitis Vaccine, adsorbed. |
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Document reference: 41412 |
Study title: Randomised, Open Trial of the lmmunogenicity and Safety of Diphtheria, Tetanus, Acellular Pertussis (DTacP) Vaccine Associated or Combined with Act-HIB Vaccine Given at 2-4-6 or 3-4-5 Months in Healthy Infants |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and inactivated Poliomyelitis Vaccine, adsorbed. |
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Document reference: 41418 |
Study title: Safety and immunogenicity of a Diphtheria, Tetanus, acellular Pertussis, enhanced inactivated trivalent Poliovirus vaccine administered separately or combined with Haemophilus influenzae type b vaccine, to healthy Chilean Infants |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and inactivated Poliomyelitis Vaccine, adsorbed. |
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Document reference: 41416 |
Study title: Safety and Immunogenicity of P.M. SV. Diphtheria, Tetanus, Acellular Pertussis, Polio (DTacP-IPV) Vaccine Given Mixed or Separately with Haemophilus influenzae type b (Act-HIBB) Vaccine, as a Primary Series. Comparison of Three Lots of DTacP-IPV Vaccine Given Combined or Separately with Act-HIB. |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and inactivated Poliomyelitis Vaccine, adsorbed. |
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Document reference: 41414 |
Study title: Study of Safety and lmmunogenicity After Simultaneous Administration of DTacP-IPV Il Act-HIB Vaccine and ROR VAX (MMR) Vaccine in 14- to 16-Month-Old Toddlers |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and inactivated Poliomyelitis Vaccine, adsorbed. |
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Document reference: 41419 |
Study title: DTPa-HBV-IPV-020 |
Active substance: diphtheria, tetanus, acellular pertussis, hepatitis b recombinant (adsorbed), inactivated poliovirus vaccine |
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Document reference: 41517 |
Study title: DTPa-HBV-IPV-055 Infanrix hexa |
Active substance: diphtheria, tetanus, acellular pertussis, hepatitis b recombinant (adsorbed), inactivated poliovirus, adsorbed conjugated haemophilus influenzae type b vaccine |
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Document reference: 41510 |
Study title: DTPa-HBV-IPV-063 |
Active substance: diphtheria, tetanus, acellular pertussis, hepatitis b recombinant (adsorbed), inactivated poliovirus, adsorbed conjugated haemophilus influenzae type b vaccine |
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Document reference: 41511 |
Study title: DTPa-HBV-IPV-070 |
Active substance: diphtheria, tetanus, acellular pertussis, hepatitis b recombinant (adsorbed), inactivated poliovirus, adsorbed conjugated haemophilus influenzae type b vaccine |
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Document reference: 41512 |
Study title: DTPa-HBV-IPV-075 |
Active substance: diphtheria, tetanus, acellular pertussis, hepatitis b recombinant (adsorbed), inactivated poliovirus, adsorbed conjugated haemophilus influenzae type b vaccine |
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Document reference: 41513 |