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Clinical trials for WI-38

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   44336   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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    13 result(s) found for: WI-38. Displaying page 1 of 1.
    EudraCT Number: 2017-001443-13 Sponsor Protocol Number: V221-027 Start Date*: 2017-04-10
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, Varicella (MMRV) Vaccine Made with an Altern...
    Medical condition: Active immunization for the prevention of measles, mumps, rubella, and varicella
    Disease: Version SOC Term Classification Code Term Level
    19.1 10021881 - Infections and infestations 10047461 Viral infection PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-001509-15 Sponsor Protocol Number: 208109/231 Start Date*: 2015-06-25
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase IIIb, open, randomized, controlled, multicenter study of the immunogenicity and safety of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine (Havrix) [720 El.U/0.5 mL dose] admini...
    Medical condition: Active immunization against hepatitis A of healthy children 15 months of age at the time of the first study vaccination.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-000454-18 Sponsor Protocol Number: 110058 Start Date*: 2017-07-10
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase II randomized, observer blind, multicenter study of GlaxoSmithKline (GSK) Biologicals’ combined measles-mumps-rubella-varicella vaccine (MMRV) versus ProQuad, according to a one dose schedu...
    Medical condition: Healthy volunteers (Use of the candidate MMRV vaccine for immunization of healthy children 12 - 14 months of age against measles, mumps, rubella and varicella).
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-005860-31 Sponsor Protocol Number: 111870 Start Date*: 2015-06-25
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Immunogenicity of GlaxoSmithKline Biologicals’ MMR vaccine (209762) vs. M-M-R® II, when co-administered with hepatitis A, varicella and pneumococcal conjugate vaccines to children 12-15 months of age
    Medical condition: Diseases caused by measles, mumps, rubella and varicella viruses
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-002946-11 Sponsor Protocol Number: 111852 Start Date*: 2015-05-22
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIb, open label, randomized, multicenter study of the im-munogenicity and safety of a booster dose of Kinrix when co-administered with varicella vaccine (Varivax®, Merck and Company) and M...
    Medical condition: Booster immunization of healthy children 4-6 years of age against diphtheria, tetanus, pertussis and polio diseases.
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-004638-32 Sponsor Protocol Number: 115158 Start Date*: 2015-06-11
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase IIIA, observer-blind, randomized study to evaluate non-inferiority of a second dose of GSK Biologicals’ measles-mumps-rubella vaccine vs. a second dose of Merck & Co., Inc.’s MMR vaccine wh...
    Medical condition: Healthy volunteers (Active immunization against measles, mumps and rubella diseases of healthy subjects, 4 to 6 years of age).
    Disease: Version SOC Term Classification Code Term Level
    18.0 10021881 - Infections and infestations 10028257 Mumps PT
    18.0 10022891 - Investigations 10059638 Mumps antibody test PT
    18.0 10021881 - Infections and infestations 10027015 Measles like illness LLT
    18.0 10021881 - Infections and infestations 10039270 Rubella viral infections HLT
    18.0 10021881 - Infections and infestations 10027011 Measles PT
    18.0 100000004858 10027022 Measles-like rash LLT
    18.0 10022891 - Investigations 10039261 Rubella immunity (confirmed) LLT
    18.0 10021881 - Infections and infestations 10028262 Mumps like illness LLT
    18.0 10021881 - Infections and infestations 10039252 Rubella PT
    18.0 10022891 - Investigations 10060066 Measles antibody PT
    18.0 10022891 - Investigations 10039255 Rubella antibodies not present LLT
    18.0 10021881 - Infections and infestations 10028268 Mumps viral infections HLT
    18.0 10022891 - Investigations 10039259 Rubella antibody test PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-004905-26 Sponsor Protocol Number: 115649 Start Date*: 2012-10-10
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Immunogenicity and safety study of GSK Biologicals’ Priorix® vaccine (209762) at an end of shelf-life potency compared to Merck & Co., Inc.’s MMR vaccine when both are given on a 2-dose schedule to...
    Medical condition: Healthy volunteers (Active immunization against measles, mumps and rubella diseases of healthy children in their second year of life).
    Disease: Version SOC Term Classification Code Term Level
    17.0 10021881 - Infections and infestations 10028257 Mumps PT
    17.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    17.0 10021881 - Infections and infestations 10039252 Rubella PT
    17.0 10021881 - Infections and infestations 10027011 Measles PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) CZ (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2011-004891-12 Sponsor Protocol Number: 115648 Start Date*: 2012-11-02
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIA, randomized, observer-blind, controlled, multinational consistency study to evaluate the immunogenicity and safety of GSK Biologicals' MMR vaccine (209762) (Priorix®) compared to Merck...
    Medical condition: Healthy volunteers (Active immunization against measles, mumps and rubella diseases of healthy children in their second year of life).
    Disease: Version SOC Term Classification Code Term Level
    18.0 10021881 - Infections and infestations 10028257 Mumps PT
    18.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    18.0 10021881 - Infections and infestations 10039252 Rubella PT
    18.0 10021881 - Infections and infestations 10027011 Measles PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: EE (Completed) FI (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2005-002352-18 Sponsor Protocol Number: 103813,105067 Start Date*: 2015-06-01
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, randomized, multinational study, double-blinded for the immunogenicity and consistency evaluation of 3 Hib-MenCY-TT vaccine lots and single-blinded and controlled for the evaluation of...
    Medical condition: Invasive disease caused by Haemophilus type b and Neisseria meningitidis serogroups C 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: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-006066-34 Sponsor Protocol Number: 105987,105988 Start Date*: 2015-06-01
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, single-blind, randomized, controlled, multinational study for the evaluation of safety of GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-t...
    Medical condition: Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10028911 Neisseria meningitidis infection NOS LLT
    18.0 100000004862 10018953 Haemophilus influenzae meningitis LLT
    18.0 100000004862 10018952 Haemophilus influenzae infection LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-003672-36 Sponsor Protocol Number: 115231,MMR159 Start Date*: 2014-10-09
    Sponsor Name:GlaxoSmithKline Biologicals S.A.
    Full Title: A Phase IIIA, observer-blind, randomized study to evaluate non-inferiority of a second dose of GSK Biologicals’ measles-mumps-rubella vaccine vs. a second dose of Merck & Co., Inc.’s MMR vaccine wh...
    Medical condition: Healthy volunteers (Active immunization against measles, mumps and rubella diseases of healthy subjects, 7 years of age and older).
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004865 10069547 Mumps immunization LLT
    17.1 100000004862 10039276 Rubella with unspecified complications LLT
    17.1 100000004865 10069545 Measles immunization LLT
    17.1 100000004862 10039274 Rubella with other specified complication LLT
    17.1 100000004865 10069564 Rubella immunization LLT
    17.1 100000004862 10028274 Mumps with other specified complication LLT
    17.1 100000004862 10027021 Measles without mention of complication LLT
    17.1 100000004862 10027020 Measles with unspecified complication LLT
    17.1 100000004858 10027022 Measles-like rash LLT
    Population Age: Children, Under 18, Adults Gender: Male, Female
    Trial protocol: SK (Completed) EE (Completed)
    Trial results: View results
    EudraCT Number: 2016-003268-37 Sponsor Protocol Number: 205239 Start Date*: 2018-09-26
    Sponsor Name:GlaxoSmithKline Biologicals SA
    Full Title: A Phase IIIB, Observer-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine when...
    Medical condition: Healthy subjects (to assess the safety and immunogenicity of Bexsero and Prevnar13 when administered concomitantly with RIV to healthy infants).
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2011-006161-18 Sponsor Protocol Number: 115650 Start Date*: 2014-09-25
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIA, randomized, observer-blind, controlled, multinational study to evaluate the safety and immunogenicity of GSK Biologicals' MMR vaccine (209762) (Priorix®) compared to Merck & Co., Inc....
    Medical condition: Healthy volunteers (Active immunization against measles, mumps and rubella diseases in healthy children, 12 to 15 months of age)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004865 10069547 Mumps immunization LLT
    18.0 100000004862 10039276 Rubella with unspecified complications LLT
    18.0 100000004862 10039274 Rubella with other specified complication LLT
    18.0 100000004865 10069545 Measles immunization LLT
    18.0 100000004865 10069564 Rubella immunization LLT
    18.0 100000004862 10028276 Mumps with unspecified complication LLT
    18.0 100000004862 10027015 Measles like illness LLT
    18.0 100000004862 10028275 Mumps with other specified complications LLT
    18.0 100000004862 10027021 Measles without mention of complication LLT
    18.0 100000004862 10027020 Measles with unspecified complication LLT
    18.0 100000004858 10027022 Measles-like rash LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: EE (Completed) FI (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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