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Clinical trials for P fimbriae

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    10 result(s) found for: P fimbriae. Displaying page 1 of 1.
    EudraCT Number: 2022-002697-80 Sponsor Protocol Number: MADI-02 Start Date*: Information not available in EudraCT
    Sponsor Name:Université Libre de Bruxelles
    Full Title: Maternal determinants of infant immunity to pertussis
    Medical condition: Vaccination against whooping cough in non-pregnant women and in pregnant women. Vaccination against whooping cough in the Belgian vaccination program in children from 2 months of age
    Disease:
    Population Age: Newborns, Infants and toddlers, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-005842-69 Sponsor Protocol Number: Td526 Start Date*: 2016-01-26
    Sponsor Name:Sanofi Pasteur Limited
    Full Title: Immune Responses in Adults to Revaccination with Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (ADACEL®) 10 Years After a Previous Dose
    Medical condition: Active immunization against tetanus, diphtheria and pertussis
    Disease: Version SOC Term Classification Code Term Level
    18.1 10042613 - Surgical and medical procedures 10054129 Diphtheria immunisation PT
    18.1 10042613 - Surgical and medical procedures 10069577 Pertussis immunisation PT
    18.1 10042613 - Surgical and medical procedures 10054131 Tetanus immunisation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-000274-37 Sponsor Protocol Number: PRI03C Start Date*: 2016-03-21
    Sponsor Name:MCM Vaccine B.V.
    Full Title: Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4- to 5 year old Children Previously Vaccinated with a 2-dose or 3-dose Infants series and Toddler dose with VAXELIS...
    Medical condition: Vaxelis is indicated for primary and booster vaccination in infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B (HB), poliomyelitis and invasive diseases caused by Haemophilus ...
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004865 10054187 Polio immunization LLT
    19.0 100000004865 10069543 Hemophilus influenzae type b immunization LLT
    19.0 100000004865 10069593 Pertussis immunization LLT
    19.0 100000004865 10054181 Hepatitis B immunization LLT
    19.0 100000004865 10054180 Diphtheria immunization LLT
    19.0 100000004865 10054183 Tetanus immunization LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2022-003923-17 Sponsor Protocol Number: SH600008 Start Date*: 2023-01-26
    Sponsor Name:Sanofi Pasteur
    Full Title: Safety and Immunogenicity Study of Full Schedule (3-Dose of Shan6™) or Shan6™-Shan5®-Shan6™ Versus the Licensed Vaccine Shan5® With bOPV (bivalent oral polio vaccine) and IPV (inactivated poliomyel...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10069577 Pertussis immunisation PT
    21.1 10042613 - Surgical and medical procedures 10054129 Diphtheria immunisation PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-002452-40 Sponsor Protocol Number: Td500056 Start Date*: 2023-03-08
    Sponsor Name:Sanofi Pasteur
    Full Title: Immune Response to Pertussis after Vaccination with a Tdap-IPV Booster Vaccine in Children in the Republic of South Africa: Effect of Homologous and Heterologous Pertussis Vaccination Priming Backg...
    Medical condition: Bacterial infections
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10069577 Pertussis immunisation PT
    21.1 10042613 - Surgical and medical procedures 10054129 Diphtheria immunisation PT
    21.1 10042613 - Surgical and medical procedures 10054131 Tetanus immunisation PT
    21.1 10042613 - Surgical and medical procedures 10053386 Poliomyelitis vaccine LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-002988-10 Sponsor Protocol Number: 212645 Start Date*: 2021-02-09
    Sponsor Name:GlaxoSmithKline Biologicals SA
    Full Title: A phase IV, single-blind, randomised, controlled, multi-country study to evaluate the immunogenicity and safety of GSK’s Infanrix hexa (DTPa-HBV-IPV/Hib) versus MCM Vaccine BV’s Vaxelis (DTaP5-HBV-...
    Medical condition: Healthy volunteers [Primary and booster immunization of infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b (...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10054187 Polio immunization LLT
    21.1 10042613 - Surgical and medical procedures 10069533 Haemophilus influenzae type b immunisation PT
    21.1 10042613 - Surgical and medical procedures 10069593 Pertussis immunization LLT
    21.1 10042613 - Surgical and medical procedures 10054181 Hepatitis B immunization LLT
    21.1 10042613 - Surgical and medical procedures 10054180 Diphtheria immunization LLT
    21.1 10042613 - Surgical and medical procedures 10054183 Tetanus immunization LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-004095-10 Sponsor Protocol Number: V419-005 Start Date*: 2012-02-20
    Sponsor Name:Sanofi Pasteur Limited
    Full Title: A Phase III Randomized, Open-Label, Active-Comparator Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V419 in Infants When Given at 2, 4, and 6 Months Conco...
    Medical condition: PR5I is developed to provide active immunization against diphtheria, tetanus, pertussis, poliomyelitis (caused by poliovirus Types 1, 2 and 3), invasive disease caused by Haemophilus influenza type...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10054130 Hepatitis B immunisation PT
    14.1 10042613 - Surgical and medical procedures 10054129 Diphtheria immunisation PT
    14.1 10042613 - Surgical and medical procedures 10053386 Poliomyelitis vaccine LLT
    14.1 10042613 - Surgical and medical procedures 10069543 Hemophilus influenzae type b immunization LLT
    14.1 10042613 - Surgical and medical procedures 10069577 Pertussis immunisation PT
    14.1 10021881 - Infections and infestations 10019731 Hepatitis B PT
    14.1 10042613 - Surgical and medical procedures 10054131 Tetanus immunisation PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-021068-13 Sponsor Protocol Number: RPV03C Start Date*: 2010-08-31
    Sponsor Name:Sanofi Pasteur MSD S.N.C.
    Full Title: An open-label, randomised, multicentre study to evaluate the immunogenicity and safety of a booster dose of diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis adsorbed vaccine ...
    Medical condition: Repevax: Antibodies response to Diphtheria Toxoid ,Tetanus Toxoid, Pertussis Toxoid*, Filamentous Haemagglutinin, Pertactin, Fimbriae Types 2 and 3, Poliomyelitis Virus Type 1, Poliomyelitis Virus ...
    Disease: Version SOC Term Classification Code Term Level
    14.0 10042613 - Surgical and medical procedures 10059429 Influenza immunisation PT
    14.0 10042613 - Surgical and medical procedures 10054129 Diphtheria immunisation PT
    14.0 10042613 - Surgical and medical procedures 10062371 Active immunization LLT
    14.0 10042613 - Surgical and medical procedures 10053386 Poliomyelitis vaccine LLT
    14.0 10042613 - Surgical and medical procedures 10069577 Pertussis immunisation PT
    14.0 10042613 - Surgical and medical procedures 10054131 Tetanus immunisation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2012-005273-31 Sponsor Protocol Number: HPARSRSG12/06 Start Date*: 2013-05-30
    Sponsor Name:Public Health England
    Full Title: A phase III/IV randomised open-label study and comparison of the immunogenicity and safety of a single adolescent booster dose of a meningococcal group C conjugate-containing booster vaccine (Menin...
    Medical condition: Prevention of meningitis C and pertussis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10006021 Booster LLT
    14.1 10021881 - Infections and infestations 10028910 Neisseria meningitides meningitis LLT
    14.1 10042613 - Surgical and medical procedures 10069577 Pertussis immunisation PT
    14.1 10042613 - Surgical and medical procedures 10069593 Pertussis immunization LLT
    14.1 10042613 - Surgical and medical procedures 10046859 Vaccination LLT
    16.0 10021881 - Infections and infestations 10027275 Meningococcal infection, unspecified LLT
    14.1 10021881 - Infections and infestations 10034738 Pertussis PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-004495-34 Sponsor Protocol Number: iMAP2 Start Date*: 2014-03-11
    Sponsor Name:Public Health England
    Full Title: A randomised controlled trial comparing two pertussis-containing vaccines in pregnancy and vaccine responses in UK mothers and their infants (immunising Mums Against Pertussis, iMAP2)
    Medical condition: No medical condition or disease, instead responses to immunisations against pertussis (whooping cough) in mothers and against pertussis (whooping cough), tetanus, diphtheria, Hib, meningococcal C a...
    Disease: Version SOC Term Classification Code Term Level
    16.1 10018065 - General disorders and administration site conditions 10059080 Vaccination site reaction PT
    16.1 10042613 - Surgical and medical procedures 10054175 Polio immunisation PT
    16.1 10042613 - Surgical and medical procedures 10054131 Tetanus immunisation PT
    16.1 10042613 - Surgical and medical procedures 10069578 Pneumococcal immunisation PT
    16.1 10042613 - Surgical and medical procedures 10054129 Diphtheria immunisation PT
    16.1 100000004862 10047976 Whooping cough due to bordetella pertussis (B. pertussis) LLT
    16.1 10042613 - Surgical and medical procedures 10069577 Pertussis immunisation PT
    16.1 10042613 - Surgical and medical procedures 10063021 Primary immunisation LLT
    16.1 10042613 - Surgical and medical procedures 10046859 Vaccination LLT
    16.1 10042613 - Surgical and medical procedures 10021430 Immunisation PT
    16.1 10042613 - Surgical and medical procedures 10069533 Haemophilus influenzae type b immunisation PT
    16.1 10018065 - General disorders and administration site conditions 10069620 Vaccination site swelling PT
    16.1 10042613 - Surgical and medical procedures 10039244 Routine vaccination LLT
    16.1 10042613 - Surgical and medical procedures 10034101 Passive immunisation LLT
    16.1 10042613 - Surgical and medical procedures 10039243 Routine immunisation LLT
    16.1 10042613 - Surgical and medical procedures 10039242 Routine childhood immunisation LLT
    Population Age: Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    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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