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Clinical trials for Polysaccharides

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    14 result(s) found for: Polysaccharides. Displaying page 1 of 1.
    EudraCT Number: 2005-002789-12 Sponsor Protocol Number: U05-PnPS-403 Start Date*: 2005-09-28
    Sponsor Name:Sanofi Pasteur MSD S.N.C
    Full Title: A double blind comparative and randomised study in healthy adults of the safety, tolerability, and immunogenicity of PNEUMOVAX®II formulated with either all new process polysaccharides or all curre...
    Medical condition: Prevention of invasive pneumococcal disease (IPD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-000260-99 Sponsor Protocol Number: 10102010 Start Date*: 2011-04-12
    Sponsor Name:Department of Genitourinary medicine and Infectious Diseases, St James's Hospital, Dublin 8
    Full Title: Immunogenicity of pneumococcal vaccination after prime boosting in HIV-Infected Adults: A Randomised Controlled Trial
    Medical condition: The primary objectives of this study are to: 1. Prospectively evaluate immunological response to vaccination with the 23-valent polysaccharide vaccine (PPV23) in HIV infected patients over a one y...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: View results
    EudraCT Number: 2014-004577-16 Sponsor Protocol Number: V59_36 Start Date*: 2014-11-07
    Sponsor Name:Novartis Vaccines and Diagnostics
    Full Title: A Phase 3b, Randomized, Open-Label, Multi-Center Study to Evaluate the Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of...
    Medical condition: Prophylaxis against Neisseria meningitidis serogroup A, C, W and Y diseases.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-005682-11 Sponsor Protocol Number: 106068, 106072 Start Date*: 2006-04-24
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase I/II, randomized, observer blinded study to evaluate and compare the safety, reactogenicity and immunogenicity of various formulations of the GlaxoSmithKline Biologicals’ adjuvanted 11-vale...
    Medical condition: Two doses vaccination in elderly subjects aged between 65 and 85 years old, in good general health and not previously immunized with the 23-valent pneumococcal polysaccharide vaccine (Pneumo 23).
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: SE (Completed) BE (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2006-000442-39 Sponsor Protocol Number: 106962 Start Date*: 2006-04-12
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: An open, phase I/II study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals’ 11PCV combined with adjuvant AS02V given as a 2-dose vaccination in adults aged 18-40 years old.
    Medical condition: Two doses vaccination in adults subjects aged between 18 and 40 years old, in good general health and not previously immunized with the 23-valent pneumococcal polysaccharide vaccine.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2012-003484-22 Sponsor Protocol Number: PNC+AHEP Start Date*: 2012-09-11
    Sponsor Name:Helsinki University Central Hospital
    Full Title: Immune response to pneumococcal conjugate vaccine in adults receiving hepatitis A vaccine concomitantly
    Medical condition: 18 years old or older volunteers with general good health
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-003692-39 Sponsor Protocol Number: PCV-ESA 2006 Start Date*: 2006-03-08
    Sponsor Name:AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO GENOVA
    Full Title: Evaluation of immunogenicity of 7-valent Pneumococcal Conjugate Vaccine (Prevenar) and Hexavalent DtPa-HBV-IPV-Hib (InfaNrix Hexa), co-administered at the same time, versus Hexavalent vaccine, use...
    Medical condition: Healthy children
    Disease: Version SOC Term Classification Code Term Level
    6.1 10062163 PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-003373-21 Sponsor Protocol Number: B7471003 Start Date*: 2020-07-16
    Sponsor Name:Pfizer, Inc.
    Full Title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
    Medical condition: Pneumococcal Infections
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-003181-39 Sponsor Protocol Number: V114-036 Start Date*: 2022-10-25
    Sponsor Name:Merck Sharp & Dohme LLC
    Full Title: A Phase 3, Single-Arm, Open-label Clinical Study to Evaluate the Safety and Immunogenicity of 4 doses of V114 Administered to Healthy Infants in South Korea.
    Medical condition: Pneumococcal disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10069594 Pneumococcal immunization LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-002718-38 Sponsor Protocol Number: 111670 Start Date*: 2015-06-10
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, open, controlled, multi-center study to evaluate the long-term antibody persistence at 1 year, 3 years and 5 years after the administration of one dose of GlaxoSmithKline (GSK) Biologic...
    Medical condition: Invasive disease caused by Neisseria meningitidis serogroups A, C W-135 and Y
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10028910 Neisseria meningitides meningitis LLT
    18.0 100000004862 10051931 Neisseria infection NOS LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-005421-59 Sponsor Protocol Number: 106388-106390 Start Date*: 2006-03-13
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, open, randomized, controlled, multicentre, primary & booster study to demonstrate the non-inferiority of the MenC & Hib immune responses of GSK Biologicals’ Hib-MenC vaccine co-adminis...
    Medical condition: Two-dose primary immunization course in healthy infants in the first year of life with a booster dose at 11 months of age against Haemophilus influenzae type b and meningococcal serogroup C diseases.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-000344-26 Sponsor Protocol Number: V211-012-00 Start Date*: 2007-06-04
    Sponsor Name:Merck & Co., Inc.
    Full Title: A Phase III Double-Blind, Randomized Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of ZOSTAVAX administered comcomitantly versus Non-concomitantly with PNEUMOVAX 23 in s...
    Medical condition: herpes zoster, pneumococcal infection
    Disease: Version SOC Term Classification Code Term Level
    9.1 10019974 Herpes zoster LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) GB (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2009-010106-11 Sponsor Protocol Number: V72P16 Start Date*: 2009-06-26
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: A Phase 2 Observer-Blind Randomized Controlled Multicenter Dose-Ranging and Formulation-Finding Study of a new Novartis Meningococcal B Recombinant Vaccine evaluating the immunogenicity, tolerabili...
    Medical condition: The Novartis Meningococcal B Recombinant±OMV NZ vaccine is intended for prevention of meningitidis and/or septicemia caused by N.meningitidis serogroup B. This study is aimed at assessing the safe...
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) IT (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2007-003786-41 Sponsor Protocol Number: V70P5 Start Date*: 2007-10-22
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: A Phase III, randomized, observer-blind, controlled, multi-center clinical study to evaluate the efficacy, safety and immunogenicity of one and two intramuscular doses of FLUAD versus control vacci...
    Medical condition: no medical, condition: healthy,
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) FI (Completed) IT (Completed) HU (Completed) BE (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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