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Clinical trials for Toxoids

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   44349   clinical trials with a EudraCT protocol, of which   7376   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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    22 result(s) found for: Toxoids. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2015-005196-24 Sponsor Protocol Number: TD9809-LT Start Date*: 2015-11-19
    Sponsor Name:Sanofi Pasteur Limited
    Full Title: Three-, Five-, and Ten-Year Data on the Long-Term Immunogenicity of Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV...
    Medical condition: Pertussis Tetanus Diphtheria Poliomyelitis Hepatitis B
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-005589-43 Sponsor Protocol Number: Td508 Start Date*: 2016-01-12
    Sponsor Name:Sanofi Pasteur Limited
    Full Title: Safety and immunogenicity of Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis (ADACEL™) Vaccine compared to Component Pertussis Vaccine and Diphtheria and Tetanus Toxoids A...
    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: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-000644-34 Sponsor Protocol Number: 108638 Start Date*: 2016-06-09
    Sponsor Name:GlaxoSmithKline Biologicals
    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)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-005845-30 Sponsor Protocol Number: Td506-LT Start Date*: 2016-01-26
    Sponsor Name:Sanofi Pasteur Limited
    Full Title: One-, Three-, Five-, and Ten-Year Data on the Long-Term Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) in Adults and Adolescents (11-64 ...
    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: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-000549-20 Sponsor Protocol Number: 106744 Start Date*: 2006-07-20
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: An open, phase IV, multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B vaccine challenge in healthy children 7 to 9 year...
    Medical condition: Four dose vaccination course with GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine or with GSK Biologicals’ HBV vaccine, given as a three dose primary vaccination series in the first year of life, followe...
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-000553-22 Sponsor Protocol Number: 106745 Start Date*: 2006-05-24
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: An open, phase IV, multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B vaccine challenge in healthy children 4-6 years o...
    Medical condition: Four dose vaccination course with GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine, given as a three-dose primary vaccination series in the first year of life, followed by a booster in the second year of ...
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2005-005519-12 Sponsor Protocol Number: V59P11 Start Date*: 2006-03-13
    Sponsor Name:CHIRON
    Full Title: A Phase 3, Multi-Center, Observer Blind, Controlled, Randomized Study to Compare the Immunogenicity and Safety of the Concomitant Administration of a Combined Tetanus, Reduced Diphtheria, and Acell...
    Medical condition: Active profilaxys against Neisseria Mengitidis type A, C, W, Y
    Disease: Version SOC Term Classification Code Term Level
    6.1 10027249 PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-003248-31 Sponsor Protocol Number: 110806 Start Date*: 2007-11-16
    Sponsor Name:GSK Biologicals
    Full Title: An open, phase IV, non-randomised, single-centre study with two study groups to assess the immunogenicity and reactogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals' combined reduced...
    Medical condition: Booster vaccination against diphtheria, tetanus and pertussis diseases in adults
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2005-003765-17 Sponsor Protocol Number: TRI05 Start Date*: 2006-01-18
    Sponsor Name:Sanofi Pasteur Inc.
    Full Title: Reactogenicity of Acellular Pertussis Vaccine Booster in Adolescents Who Have Received 5 Prior Doses Of BIKEN Acellular Pertussis Vaccine in Combination with Diphtheria and Tetanus Toxoids (Tripedi...
    Medical condition: prophylaxis
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-001507-31 Sponsor Protocol Number: 111535 Start Date*: 2015-06-09
    Sponsor Name:GlaxoSmithKline Biologicals - GSK China Vaccines
    Full Title: A phase IIIb, open-label, multicentre study to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ combined diphtheria-tetanus-acellular pertussis (DTPa)- Haemophilus influen...
    Medical condition: Healthy volunteers (Booster immunisation of healthy children in the second year of life against diphtheria, tetanus, pertussis and Haemophilus influenzae type b diseases).
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-001484-39 Sponsor Protocol Number: 444563/022 Start Date*: 2015-06-11
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, double-blind, randomized, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of three doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated huma...
    Medical condition: Rotavirus Gastroenteritis
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2007-005343-16 Sponsor Protocol Number: 111344 Start Date*: 2008-02-07
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, open, study to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine when administered as a booster dose to children aged ...
    Medical condition: Booster immunisation of healthy toddlers in the second year of life against diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae type b.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2015-001511-12 Sponsor Protocol Number: 109861 Start Date*: 2015-06-10
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, single group, open study to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine in Taiwan when co-admini...
    Medical condition: Healthy volunteers (Three dose primary vaccination against Streptococcus pneumoniae, diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b diseases and a two dose primar...
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10042197 Streptococcus pneumoniae septicaemia LLT
    18.0 100000004862 10042195 Streptococcus pneumoniae pneumonia LLT
    18.0 100000004862 10054642 Streptococcus pneumoniae septicemia LLT
    18.0 100000004862 10035648 Pneumococcal pneumonia [Streptococcus pneumoniae pneumonia] LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-001095-21 Sponsor Protocol Number: A5I16 Start Date*: 2016-04-19
    Sponsor Name:Sanofi Pasteur Inc.
    Full Title: Immunogenicity and Safety of PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus influenzae Type b Conjugate Vaccine (Adsorbed),...
    Medical condition: Pertussis, adsorbed diphtheria and tetanus toxoids, inactivated poliomyelitis and polysaccharide of H. influenza type b bound to tetanus toxoid
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-003950-41 Sponsor Protocol Number: Td536 Start Date*: 2016-01-13
    Sponsor Name:SANOFI PASTEUR SA
    Full Title: Immunogenicity and safety of the tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (SP306) given intramuscularly compared to Diphtheria and Tetanus toxoids adsorbed...
    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: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-004221-25 Sponsor Protocol Number: PRI02C Start Date*: 2013-03-12
    Sponsor Name:Sanofi Pasteur MSD
    Full Title: A phase 3 open-label study to evaluate the immunogenicity and safety of a mixed (HEXA/PENTA/HEXA) primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel® at 4 month...
    Medical condition: Healthy infants greater than or equal to 46 days and less than or equal to 74 days of age on the day of inclusion
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004865 10054187 Polio immunization LLT
    16.0 100000004865 10069543 Hemophilus influenzae type b immunization LLT
    16.0 100000004865 10069593 Pertussis immunization LLT
    16.0 100000004865 10054181 Hepatitis B immunization LLT
    16.0 100000004865 10054180 Diphtheria immunization LLT
    16.0 100000004865 10054183 Tetanus immunization LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2008-004907-69 Sponsor Protocol Number: H-030-011 Start Date*: 2008-11-25
    Sponsor Name:Sanofi Pasteur Inc.
    Full Title: A Phase II randomized, placebo-controlled, double-blind, dose ranging study of a Clostridium difficile toxoid vaccine (ACAM-CDIFF) in subjects with Clostridium difficile-associated infection(CDI)
    Medical condition: Recurrence of Clostridium difficile Infection (CDI)
    Disease: Version SOC Term Classification Code Term Level
    12.0 10006834 C.difficile diarrhea LLT
    12.0 10006835 C.difficile diarrhoea LLT
    12.0 10012734 Diarrhea, Clostridium difficile LLT
    12.0 10012748 Diarrhoea, Clostridium difficile LLT
    12.0 10022661 Intestinal infection due to clostridium difficile LLT
    12.0 10054236 Clostridium difficile infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-004644-22 Sponsor Protocol Number: 111188 Start Date*: 2015-06-17
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, randomized, single-blind, controlled study to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine as a 3...
    Medical condition: Healthy volunteers (Three dose primary vaccination of healthy infants between 6 to 10 weeks of age at the time of the first vaccination against Streptococcus pneumoniae, diphtheria, tetanus, pertus...
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10042197 Streptococcus pneumoniae septicaemia LLT
    18.0 100000004862 10042195 Streptococcus pneumoniae pneumonia LLT
    18.0 100000004862 10054642 Streptococcus pneumoniae septicemia LLT
    18.0 100000004862 10035648 Pneumococcal pneumonia [Streptococcus pneumoniae pneumonia] LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-000557-21 Sponsor Protocol Number: 107007 Start Date*: 2015-06-17
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIb randomized, double-blind, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine compar...
    Medical condition: Healthy volunteers (Three dose primary vaccination of healthy infants between 6 to 12 weeks of age at the time of the first vaccination against Streptococcus pneumoniae)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10042197 Streptococcus pneumoniae septicaemia LLT
    18.0 100000004862 10042195 Streptococcus pneumoniae pneumonia LLT
    18.0 100000004862 10054642 Streptococcus pneumoniae septicemia LLT
    18.0 100000004862 10035648 Pneumococcal pneumonia [Streptococcus pneumoniae pneumonia] LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-004109-21 Sponsor Protocol Number: V114-029 Start Date*: 2021-06-10
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 4-dose Regimen of V114 in Healthy Infants (PNEU-PED)
    Medical condition: Prevention of pneumococcal disease associated with serotypes included in the vaccine.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10061353 Pneumococcal infection PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
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