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Clinical trials for COVID-19 AND vaccine AND children

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   43861   clinical trials with a EudraCT protocol, of which   7284   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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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    15 result(s) found for: COVID-19 AND vaccine AND children. Displaying page 1 of 1.
    EudraCT Number: 2021-002613-34 Sponsor Protocol Number: NL76336.041.21 Start Date*: 2021-06-30
    Sponsor Name:University Medical Center Utrecht
    Full Title: Prospective monitoring of antibody response following COVID-19 vaccination in patients with Down Syndrome
    Medical condition: Persons with Down syndrome
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-003388-90 Sponsor Protocol Number: PB21VAC Start Date*: 2021-07-05
    Sponsor Name:Princess Máxima Center for Pediatric Oncology
    Full Title: Prospective monitoring of immune response following COVID-19 vaccination in children with cancer
    Medical condition: Children with cancer, receiving COVID-19 vaccination
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-000281-15 Sponsor Protocol Number: mRNA-1273-P204 Start Date*: 2023-09-19
    Sponsor Name:ModernaTX, Inc.
    Full Title: A Phase 2/3, Three-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and ...
    Medical condition: Coronavirus Disease 2019
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2021-002693-10 Sponsor Protocol Number: VAC3_SARS-CoV2_seroconversion_study Start Date*: 2021-07-15
    Sponsor Name:Medical University of Vienna, Department for Internal Medicine III, Division of Rheumatology
    Full Title: A Phase II Study to Evaluate Safety and Efficacy to a Third Vaccination in Immunocompromised Patients with Inadequate Humoral Response after Primary mRNA SARS-CoV-2 (Covid-19) Vaccination
    Medical condition: Vaccination against SARS-CoV-2 in patients with immunosuppressive therapy or immunodeficiencies
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001228-32 Sponsor Protocol Number: COV002 Start Date*: 2020-05-04
    Sponsor Name:CTRG
    Full Title: A phase 2/3 study to determine the efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19
    Medical condition: SARS-CoV-2
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2021-005043-71 Sponsor Protocol Number: EU-COVPT-1 Start Date*: 2021-11-24
    Sponsor Name:University Medical Center Utrecht
    Full Title: A Phase 2, Comparative Randomised Trial to Evaluate the impact of reduced COVID-19 mRNA vaccination regimens on immunological responses and reactogenicity in paediatric subjects with and without pr...
    Medical condition: Healthy volunteers (paediatric subjects) with or without prior SARS-CoV-2 infection
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004865 10084464 COVID-19 immunization LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing) NO (Ongoing) DE (Prematurely Ended) SE (Ongoing) GR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-002966-41 Sponsor Protocol Number: APHP210639 Start Date*: 2021-08-13
    Sponsor Name:Assistance Publique – Hôpitaux de Paris / DRCI
    Full Title: Anti-Covid-19 vaccine protection in immunocompromised children (1-15 years) with acute leukemia and their siblings (≥ 12 years). Phase I-II trial evaluating safety and post-vaccination humoral and ...
    Medical condition: - Children aged 1-15 years with LA undergoing chemotherapy or whose last chemotherapy session date is less than or equal to 12 months. - Siblings of children with LA (living in the same household...
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000835 Acute leukemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-002348-57 Sponsor Protocol Number: 2021-002348-57 Start Date*: 2021-05-30
    Sponsor Name:Medical University of Vienna
    Full Title: A Randomized, Parallel Group, Single-Blind, Phase 2 Study to Evaluate the immune response of two classes of SARS-Cov-2 Vaccines employed as Third Vaccination in Patients under current Rituximab The...
    Medical condition: Vaccination against SARS-CoV-2 in patients with rituximab therapy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2020-002584-63 Sponsor Protocol Number: VAC31518COV2001 Start Date*: 2020-09-02
    Sponsor Name:Janssen Vaccines & Prevention B.V.
    Full Title: A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults Aged 18 to 55 Years Inclusive and Adults ...
    Medical condition: Healthy Volunteers (Prevention of COVID-19)
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004865 10084465 COVID-19 vaccination LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) ES (Restarted) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2024-000001-33 Sponsor Protocol Number: C4591048 Start Date*: 2024-02-07
    Sponsor Name:BioNTech SE
    Full Title: A Master Phase 1/2/3 Protocol to Investigate the Safety, Tolerability, and Immunogenicity of Variant-Adapted BNT162b2 RNA-Based Vaccine Candidate(s) in Healthy Children
    Medical condition: Protection against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2)
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    23.0 10021881 - Infections and infestations 10084510 Coronavirus infections HLT
    23.1 10021881 - Infections and infestations 10084529 2019 novel coronavirus infection LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-005442-42 Sponsor Protocol Number: C4591007 Start Date*: 2021-04-28
    Sponsor Name:BioNTech SE
    Full Title: A PHASE 1, OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY, AND IMMUNOGENICITY AND PHASE 2/3 PLACEBOCONTROLLED, OBSERVER-BLINDED SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF A S...
    Medical condition: Protection against COVID-19
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005330-14 Sponsor Protocol Number: VAC31518COV2004 Start Date*: 2021-04-06
    Sponsor Name:Janssen Vaccines & Prevention B.V.
    Full Title: An Open-label, Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Healthy Pregnant Participants.
    Medical condition: Healthy Pregnant Volunteers (Prevention of SARS-CoV-2-mediated COVID-19)
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004865 10084465 COVID-19 vaccination LLT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-002479-20 Sponsor Protocol Number: 80202135MYG2001 Start Date*: 2022-09-29
    Sponsor Name:Janssen-Cilag Invernational N.V.
    Full Title: An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to less than 18 years with Generalized Myasthe...
    Medical condition: Myasthenia gravis (MG)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10028417 Myasthenia gravis PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) Outside EU/EEA PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-001290-23 Sponsor Protocol Number: C4591024 Start Date*: Information not available in EudraCT
    Sponsor Name:BioNTech SE
    Full Title: A PHASE 2b, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF VACCINE CANDIDATE BNT162b2 IN IMMUNOCOMPROMISED PARTICIPANTS ≥2 YEARS OF AGE
    Medical condition: Protection against COVID-19
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: View results
    EudraCT Number: 2022-003307-16 Sponsor Protocol Number: OMT28-C0203 Start Date*: 2023-04-18
    Sponsor Name:OMEICOS Therapeutics GmbH
    Full Title: A Phase 2a Safety, Tolerability, and Pharmacodynamic Study of OMT-28 in PMD patients with myopathy and/or cardiomyopathy and inflammation (PMD-OPTION)
    Medical condition: Primary Mitochondrial Disease (PMD)
    Disease: Version SOC Term Classification Code Term Level
    22.0 10010331 - Congenital, familial and genetic disorders 10052641 Mitochondrial DNA mutation PT
    22.0 10010331 - Congenital, familial and genetic disorders 10052641 Mitochondrial DNA mutation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing) DE (Ongoing)
    Trial results: (No results available)
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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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