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Clinical trials for Pentavalent vaccine

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   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 ).  
     
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    16 result(s) found for: Pentavalent vaccine. Displaying page 1 of 1.
    EudraCT Number: 2012-001611-23 Sponsor Protocol Number: V260-035 Start Date*: 2012-09-28
    Sponsor Name:Merck Sharp & Dohme Corp., una filial de Merck & Co., Inc.
    Full Title: A Double-Blind, Randomized, COntrolled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq(TM)
    Medical condition: Prevention of rotavirus gastroenteritis in infants and children caused by serotypes G1, G2, G3, G4, and G serotypes that contain P1A[8] (e.g., G9)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10039232 Rotavirus gastroenteritis LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) SE (Completed) FI (Completed) CZ (Completed) PL (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2017-000263-32 Sponsor Protocol Number: V260-028 Start Date*: 2017-03-07
    Sponsor Name:Merck & Co., Inc.
    Full Title: A Double-Blind, Randomized, Placebo-Controlled, Safety and Tolerability Study of Live Pentavalent Human-Bovine Rotavirus Reassortant Vaccine in Chinese Healthy Adults, Children and Infants
    Medical condition: Prevention of Rotavirus Gastroenteritis Caused by Serotypes G1, G2, G3, G4, and G-Serotypes Associated With P1A [8] (e.g., G9) in Infants
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004862 10039232 Rotavirus gastroenteritis LLT
    Population Age: Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-005159-25 Sponsor Protocol Number: V260-024-01 Start Date*: 2016-12-16
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants
    Medical condition: Prevention of rotavirus gastroenteritis
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-000277-37 Sponsor Protocol Number: V260-060 Start Date*: 2017-03-10
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: Post-marketing, Randomized, Open-label Study to Assess the Immunogenicity and Safety of Concomitant Administration of V260 and Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP...
    Medical condition: Prevention of Rotavirus Gastroenteritis Caused by Serotypes G1, G2, G3, G4, and G-Serotypes Associated With P1A [8] (e.g., G9) in Infants
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004862 10039232 Rotavirus gastroenteritis LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-000264-15 Sponsor Protocol Number: V260-029 Start Date*: 2017-03-07
    Sponsor Name:Banyu Pharmaceutical Co., Ltd. a subsidiary of Merck & Co.,Inc, Kenilworth, New Jersey, USA
    Full Title: A phase III randomized, placebo-controlled clinical trial to study the efficacy and safety of V260 in healthy infants in Japan
    Medical condition: Prevention of Rotavirus Gastroenteritis Caused by Serotypes G1, G2, G3, G4, and G-Serotypes Associated With P1A [8] (e.g., G9) in Infants
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004862 10039232 Rotavirus gastroenteritis LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2007-003852-13 Sponsor Protocol Number: V504-001-00 Start Date*: 2007-11-09
    Sponsor Name:Merck Sharp & Dohme (Sweden) AB
    Full Title: A Randomized, Double-Blinded, Tolerability and Immunogenicity Study of a Multivalent Human Papillomavirus (HPV) L1 Virus- Like Particle (VLP) Vaccine (V504) Administered Concomitantly with GARDASIL...
    Medical condition: Prevention of cervical, vulvar, and vaginal cancers and related precancers, external genital lesions, and persistent infection caused by Human Papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52, an...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10063001 Human papilloma virus infection LLT
    Population Age: Adults Gender: Female
    Trial protocol: SE (Completed) AT (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2014-005309-18 Sponsor Protocol Number: V66_05 Start Date*: 2014-12-10
    Sponsor Name:Novartis Vaccines and Diagnostics
    Full Title: A Ph III, Single Arm, Multi-Center, Open-Label Study to Assess the Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent Vaccine Quinvaxem® (DTwP-Hib-HepB Vaccine) when Administered...
    Medical condition: Prophilaxis against diphtheria, tetanus, pertussis, hepatitis B and invasive Haemophilus influenzae type b disease.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-005445-11 Sponsor Protocol Number: S06-ROT-304 Start Date*: 2006-12-13
    Sponsor Name:Sanofi Pasteur MSD S.N.C.
    Full Title: An open-label, randomised, comparative, multi-centre study of the immunogenicity and safety of the concomitant use of a live pentavalent rotavirus vaccine (RotaTeq®) and a meningococcal group C con...
    Medical condition: RotaTeq® is indicated for the active immunisation of infants from age of 6 weeks for prevention of gastroenteritis due to rotavirus infection. NeisVac-C® is indicated for active immunisation of ch...
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2023-000924-13 Sponsor Protocol Number: VAN00010 Start Date*: 2023-12-21
    Sponsor Name:Sanofi Pasteur Inc.
    Full Title: A Phase I/II, Randomized, Descriptive, Safety and Immunogenicity study to assess Pentavalent Meningococcal ABCYW Vaccine formulations in Adults (18 to 25 years of age) and Adolescents (10 to 17 yea...
    Medical condition: Bacterial infections and mycoses
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10027274 Meningococcal infection PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2018-001472-38 Sponsor Protocol Number: MET57 Start Date*: 2018-07-10
    Sponsor Name:Sanofi Pasteur Inc.
    Full Title: Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Other Pediatric Vaccines in Healthy Toddlers
    Medical condition: Healthy volunteers (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y or W)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10027274 Meningococcal infection PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2023-000944-46 Sponsor Protocol Number: 217218 Start Date*: 2024-05-31
    Sponsor Name:GLAXOSMITHKLINE BIOLOGICALS SA
    Full Title: A Phase IIa observer-blind, randomized, controlled, age-de-escalation, single center interventional study to evaluate the safety, reactogenicity, and immune response of the GVGH iNTS vaccine agains...
    Medical condition: Prevention of invasive nontyphoidal Salmonella disease
    Disease:
    Population Age: Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2005-003508-12 Sponsor Protocol Number: 010-01 Start Date*: 2006-02-28
    Sponsor Name:Merck and Co., Inc.
    Full Title: Safety and Immunogenicity of Concomitant Use of RotaTeq™ and INFANRIX™ Hexa in Healthy Children
    Medical condition: RotaTeq is an oral pentavalent vaccine indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, G4, and G-serotypes that contain P1 (e.g...
    Disease: Version SOC Term Classification Code Term Level
    10 10017913 LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) AT (Completed)
    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: 2012-001042-18 Sponsor Protocol Number: A3L40 Start Date*: 2014-08-19
    Sponsor Name:Sanofi Pasteur SA
    Full Title: This Phase III multi-center study of DTaP-IPV-Hib, with or without Hep B, used as a booster vaccine in healthy infants and toddlers will be conducted with two controlled, blind-observer trial arms ...
    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...
    Disease: Version SOC Term Classification Code Term Level
    17.0 10042613 - Surgical and medical procedures 10036897 Prophylactic vaccination LLT
    17.0 10042613 - Surgical and medical procedures 10043413 Therapeutic procedures and supportive care NEC HLGT
    17.0 10042613 - Surgical and medical procedures 10021430 Immunisation PT
    17.0 10042613 - Surgical and medical procedures 10021431 Immunisations HLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) ES (Completed)
    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: 2016-004421-17 Sponsor Protocol Number: B1971057 Start Date*: 2020-02-17
    Sponsor Name:Pfizer Inc. 235 East 42nd Street, New York, NY 10017
    Full Title: A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED STUDY TO ASSESS THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF BIVALENT rLP2086 WHEN ADMINISTERED AS A 2-DOSE REGIMEN AND A FIRST-IN-HUMA...
    Medical condition: Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W and Y in individuals 10 through 25 years of age.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10027249 Meningitis meningococcal PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: CZ (Completed) FI (Completed) PL (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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