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Clinical trials for Reactogenicity

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 ).  
     
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    507 result(s) found for: Reactogenicity. Displaying page 1 of 26.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2021-000548-23 Sponsor Protocol Number: UKE-SARS-COV-2-ST Start Date*: 2021-07-07
    Sponsor Name:University Medical Center Hamburg-Eppendorf
    Full Title: A multi-center, phase Ib trial to assess the safety, tolerability and immunogenicity of the candidate vaccine MVA-SARS-2-ST in adults
    Medical condition: This study is designed to evaluate the safety, tolerability and reactogenicity of intramuscular dose administrations of: -3 dose levels of the MVA-SARS-2-ST vaccine in healthy SARS-CoV-2 seronegati...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-001608-32 Sponsor Protocol Number: 112683 Start Date*: 2017-11-14
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: An open-label study to assess the safety and reactogenicity of GlaxoSmithKline Biologicals’ Inactivated Poliomyelitis Vaccine Poliorix administered as a booster dose at 18-24 months of age in healt...
    Medical condition: Healthy volunteers (Poliomyelitis)
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-001481-16 Sponsor Protocol Number: 113518 Start Date*: 2015-05-13
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase I, double-blind, randomised, placebo-controlled study to assess the reactogenicity and safety of two doses of GlaxoSmithKline Biologicals’ (GSK) oral live attenuated liquid human rotavirus ...
    Medical condition: Healthy volunteers (Active immunisation of infants against gastroenteritis (GE) due to rotavirus (RV))
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-000451-14 Sponsor Protocol Number: 112896 Start Date*: 2017-06-01
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: An open, single group, multi-centric, post marketing surveillance (PMS) to monitor the reactogenicity and safety of oral live attenuated human rotavirus (HRV) vaccine, Rotarix when administered acc...
    Medical condition: Healthy volunteers (Active immunisation of infants from the age of 6 weeks for prevention of gastroenteritis due to rotavirus infection).
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-001546-28 Sponsor Protocol Number: 111664 Start Date*: 2015-06-11
    Sponsor Name:Smithkline Beecham Pvt Limited
    Full Title: Open, multi-centric, post-marketing surveillance (PMS) to evaluate the reactogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccin...
    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: 2015-001513-27 Sponsor Protocol Number: 112065 Start Date*: 2015-06-10
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: An open-label primary vaccination study to assess the safety and reactogenicity of GlaxoSmithKline Biologicals’ combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus in...
    Medical condition: Healthy volunteers (Primary immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, poliomyelitis 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: 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: 2017-000458-20 Sponsor Protocol Number: 108160 Start Date*: 2017-11-14
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A post-marketing surveillance (PMS) study to monitor the safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ human papillo-mavirus (HPV) vaccine (Cervarix) in 3,000 healthy female Filip...
    Medical condition: Healthy volunteers (active immunization against Human papillomavirus infection in female subjects for the prevention of cervical cancer).
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-001607-80 Sponsor Protocol Number: 112581 Start Date*: 2017-11-14
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: An open-label primary vaccination study to assess the safety and reactogenicity of GlaxoSmithKline Biologicals’ Inactivated Poliomyelitis vaccine Poliorix administered as a three-dose primary vacci...
    Medical condition: Healthy volunteers (Poliomyelitis)
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-001713-26 Sponsor Protocol Number: CYD28 Start Date*: 2014-05-26
    Sponsor Name:Sanofi Pasteur SA
    Full Title: Immunogenicity and Large-Scale Safety of Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Singapore
    Medical condition: Prevention of symptomatic dengue disease
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-005036-33 Sponsor Protocol Number: M37P1 Start Date*: 2014-11-18
    Sponsor Name:Novartis Vaccines and Diagnostics
    Full Title: A phase I study to investigate safety and reactogenicity of Vaxem Hib in healthy children aged 16 – 20 months and infants aged 2 - 4 months.
    Medical condition: Meningitis, epiglottitis, pneumonia, arthritis caused by Haemophilus influenzae type b.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-001707-53 Sponsor Protocol Number: CYD13 Start Date*: 2014-05-26
    Sponsor Name:Sanofi Pasteur SA
    Full Title: Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America
    Medical condition: Prevention of symptomatic dengue disease
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-001715-39 Sponsor Protocol Number: CYD30 Start Date*: 2014-05-26
    Sponsor Name:Sanofi Pasteur SA
    Full Title: Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America
    Medical condition: Prevention of symptomatic dengue disease
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-005203-24 Sponsor Protocol Number: V37_11 Start Date*: 2014-12-10
    Sponsor Name:Novartis Vaccines and Diagnostics
    Full Title: A Post Marketing Surveillance Study to monitor the reactogenicity and safety of Vaxem™Hib when administered according to the prescribing information in Korea
    Medical condition: Meningitis, epiglottitis, pneumonia, arthritis caused by Haemophilus influenzae type b.
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-004039-21 Sponsor Protocol Number: 103366 Start Date*: 2015-05-20
    Sponsor Name:GlaxoSmithKline
    Full Title: An open, multicentric, post-marketing surveillance study to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals’ live attenuated oral Human Rotavirus (HRV) vaccine, Rotarix when a...
    Medical condition: Healthy volunteers (Rotarix is indicated for the prevention of gastro-enteritis caused by Rotavirus, G1 and non G1 serotypes (such as G2, G3, G4, G9))
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 2004-003768-32 Sponsor Protocol Number: 103533, 103534 Start Date*: 2005-01-11
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase II, open (partially double-blind), randomized, controlled dose-range study to evaluate the immunogenicity, reactogenicity and safety of four different formulations of GlaxoSmithKline (GSK) ...
    Medical condition: Primary immunization of healthy children aged 12-14 months and 3-5 years against meningococcal serogroups A, C, W-135 and Y diseases.
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2014-001717-11 Sponsor Protocol Number: CYD32 Start Date*: 2014-05-26
    Sponsor Name:Sanofi Pasteur SA
    Full Title: Study of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia
    Medical condition: Prevention of symptomatic dengue disease
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-003859-37 Sponsor Protocol Number: 115739 Start Date*: 2015-03-09
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, single-group, open-label study to assess the safety and reactogenicity of GSK Biologicals’ combined reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine Boostr...
    Medical condition: Booster immunisation against diphtheria, tetanus and pertussis diseases in healthy children aged four years and above.
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-002538-18 Sponsor Protocol Number: 115389 Start Date*: 2015-05-27
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, single-group, open-label, multicentre study to assess the safety and reactogenicity of GlaxoSmithKline Biologicals’ combined diphtheria-tetanus-acellular pertussis-inactivated poliovir...
    Medical condition: Booster vaccination of healthy toddlers in the second year of life against diphtheria, tetanus, pertussis, poliomyelitis 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
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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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