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Clinical trials for Pentaxim

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • 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   44334   clinical trials with a EudraCT protocol, of which   7366   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 ).  
     
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    11 result(s) found for: Pentaxim. Displaying page 1 of 1.
    EudraCT Number: 2014-001736-11 Sponsor Protocol Number: CYD33 Start Date*: 2014-05-26
    Sponsor Name:Sanofi Pasteur SA
    Full Title: Immunogenicity and Safety of a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly with Tetravalent Dengue Vaccine in Healthy Toddlers Aged 15 to 18 Months in Mexico
    Medical condition: Prevention of symptomatic dengue disease
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-005404-29 Sponsor Protocol Number: E2I60 Start Date*: 2015-12-04
    Sponsor Name:SANOFI PASTEUR SA
    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...
    Disease: Version SOC Term Classification Code Term Level
    18.1 10042613 - Surgical and medical procedures 10036897 Prophylactic vaccination LLT
    18.1 10042613 - Surgical and medical procedures 10043413 Therapeutic procedures and supportive care NEC HLGT
    18.1 10042613 - Surgical and medical procedures 10021430 Immunisation PT
    18.1 10042613 - Surgical and medical procedures 10021431 Immunisations HLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-002873-36 Sponsor Protocol Number: A3L31 Start Date*: 2016-07-08
    Sponsor Name:Sanofi Pasteur SA
    Full Title: Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T Combined Vaccine at 2, 4, and 6 Months of Age versus Sanofi Pasteur's DTaP-IPV//PRP~T Combined Vaccine at 2, 4, and 6 Months of Ag...
    Medical condition: Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b infection, Poliomyelitis, and Hepatitis B
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-005352-10 Sponsor Protocol Number: E2I34 Start Date*: 2015-12-04
    Sponsor Name:SANOFI PASTEUR INTERNATIONAL
    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...
    Disease: Version SOC Term Classification Code Term Level
    18.1 10042613 - Surgical and medical procedures 10036897 Prophylactic vaccination LLT
    18.1 10042613 - Surgical and medical procedures 10043413 Therapeutic procedures and supportive care NEC HLGT
    18.1 10042613 - Surgical and medical procedures 10021430 Immunisation PT
    18.1 10042613 - Surgical and medical procedures 10021431 Immunisations HLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-005354-35 Sponsor Protocol Number: E2I43 Start Date*: 2015-12-04
    Sponsor Name:SANOFI PASTEUR INTERNATIONAL
    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...
    Disease: Version SOC Term Classification Code Term Level
    18.1 10042613 - Surgical and medical procedures 10036897 Prophylactic vaccination LLT
    18.1 10042613 - Surgical and medical procedures 10043413 Therapeutic procedures and supportive care NEC HLGT
    18.1 10042613 - Surgical and medical procedures 10021430 Immunisation PT
    18.1 10042613 - Surgical and medical procedures 10021431 Immunisations HLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-005293-38 Sponsor Protocol Number: E2I49 Start Date*: 2015-12-04
    Sponsor Name:SANOFI PASTEUR SA
    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...
    Disease: Version SOC Term Classification Code Term Level
    18.1 10042613 - Surgical and medical procedures 10036897 Prophylactic vaccination LLT
    18.1 10042613 - Surgical and medical procedures 10043413 Therapeutic procedures and supportive care NEC HLGT
    18.1 10042613 - Surgical and medical procedures 10021430 Immunisation PT
    18.1 10042613 - Surgical and medical procedures 10021431 Immunisations HLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-004454-26 Sponsor Protocol Number: A3L10 Start Date*: 2012-04-10
    Sponsor Name:Sanofi Pasteur SA
    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...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10021430 Immunisation PT
    14.1 10042613 - Surgical and medical procedures 10036897 Prophylactic vaccination LLT
    14.1 10042613 - Surgical and medical procedures 10021431 Immunisations HLT
    14.1 10042613 - Surgical and medical procedures 10043413 Therapeutic procedures and supportive care NEC HLGT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-004432-58 Sponsor Protocol Number: A3L22 Start Date*: 2012-04-10
    Sponsor Name:Sanofi Pasteur SA
    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...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10021430 Immunisation PT
    14.1 10042613 - Surgical and medical procedures 10036897 Prophylactic vaccination LLT
    14.1 10042613 - Surgical and medical procedures 10021431 Immunisations HLT
    14.1 10042613 - Surgical and medical procedures 10043413 Therapeutic procedures and supportive care NEC HLGT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-005353-12 Sponsor Protocol Number: E2I42 Start Date*: 2015-12-04
    Sponsor Name:SANOFI PASTEUR SA
    Full Title: Immunogenicity and 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 or 3, 4 and 5 Months of Age and followed by a Bo...
    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...
    Disease: Version SOC Term Classification Code Term Level
    18.1 10042613 - Surgical and medical procedures 10036897 Prophylactic vaccination LLT
    18.1 10042613 - Surgical and medical procedures 10043413 Therapeutic procedures and supportive care NEC HLGT
    18.1 10042613 - Surgical and medical procedures 10021430 Immunisation PT
    18.1 10042613 - Surgical and medical procedures 10021431 Immunisations HLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-005403-87 Sponsor Protocol Number: E2I57 Start Date*: 2015-12-04
    Sponsor Name:SANOFI PASTEUR SA
    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.
    Disease: Version SOC Term Classification Code Term Level
    18.1 10042613 - Surgical and medical procedures 10036897 Prophylactic vaccination LLT
    18.1 10042613 - Surgical and medical procedures 10043413 Therapeutic procedures and supportive care NEC HLGT
    18.1 10042613 - Surgical and medical procedures 10021430 Immunisation PT
    18.1 10042613 - Surgical and medical procedures 10021431 Immunisations HLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-006204-11 Sponsor Protocol Number: 6096A1-3000 Start Date*: Information not available in EudraCT
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc.
    Full Title: A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Manufacturing Scale 13-valent Pneumococcal Conjugate Vaccine
    Medical condition: Healthy infants
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: PL (Ongoing)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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