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Clinical trials for Neonatal tetanus

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   44335   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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    7 result(s) found for: Neonatal tetanus. Displaying page 1 of 1.
    EudraCT Number: 2018-002976-41 Sponsor Protocol Number: ZonMW522004008 Start Date*: 2019-07-09
    Sponsor Name:RIVM
    Full Title: ‘Premature infants and maternal pertussis immunization. Is second trimester vaccination beneficial?’
    Medical condition: women in their first trimester of pregnancy
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-005718-20 Sponsor Protocol Number: 111315 Start Date*: 2015-04-01
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase 2, open, randomized, controlled, multi-center study to evaluate the safety and immunogenicity of 7 infant immunization schedules of the RTS,S/AS01E candidate vaccine against P. falciparum.
    Medical condition: Healthy volunteers (Primary immunization against Plasmodium falciparum malaria)
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-003762-33 Sponsor Protocol Number: 106481 Start Date*: 2006-12-06
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIb, double blind, randomised, placebo–controlled, multi–country, multicentre study to assess the safety, reactogenicity and immunogenicity of two doses of GlaxoSmithKline (GSK) Biological...
    Medical condition: Primary immunisation of pre–term infants against human rotavirus gastroenteritis (GE)
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) PT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2015-001540-10 Sponsor Protocol Number: 444563/024 Start Date*: 2015-06-11
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, double-blind, randomised, placebo-controlled, multi-country and multi-center study to assess the efficacy, immunogenicity and safety of two doses of GSK Biologicals’ oral live attenuat...
    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: 2012-000254-64 Sponsor Protocol Number: 114056 Start Date*: 2012-04-12
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, open, controlled study to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10- valent pneumococcal conjugate vaccine administered to children with sickle cell...
    Medical condition: Active immunization against disease caused by Streptococcus pneumoniae in children from 8 weeks up to 2 years of age.
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10061190 Haemophilus infection PT
    17.1 10021881 - Infections and infestations 10061353 Pneumococcal infection PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-001119-38 Sponsor Protocol Number: 116945 Start Date*: 2015-09-21
    Sponsor Name:GlaxoSmithKline
    Full Title: A Phase IV, observer-blind, randomised, cross-over, placebo-controlled, multicentre study to assess the immunogenicity and safety of a single dose of Boostrix? in pregnant women.
    Medical condition: Booster immunisation against diphtheria, tetanus and pertussis diseases. The study population for this study will include pregnant women.
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10047976 Whooping cough due to bordetella pertussis (B. pertussis) LLT
    18.0 100000004862 10009663 Clostridium tetani infection LLT
    18.0 100000004862 10054237 Corynebacterium diphtheriae infection LLT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Completed) CZ (Completed) FI (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-003124-41 Sponsor Protocol Number: 219510 Start Date*: 2023-03-27
    Sponsor Name:GlaxoSmithKline Biologicals SA
    Full Title: A Phase 3b, non-randomized, open label, multi-country, cohort study to describe the safety of study participants who received RSVPreF3 maternal vaccination (any dose) or controls from previous RSV ...
    Medical condition: Pregnancy related outcomes and events in maternal participants who were vaccinated against RSV or received control, and in their infants
    Disease: Version SOC Term Classification Code Term Level
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10070538 Gestational hypertension PT
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10036485 Pre-eclampsia PT
    25.0 10036585 - Pregnancy, puerperium and perinatal conditions 10086971 Pre-eclampsia with severe features LLT
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10070532 Fetal growth restriction LLT
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10073024 Preterm premature rupture of membranes PT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10075863 Preterm labor LLT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10018210 Gestational diabetes mellitus LLT
    20.0 100000004862 10008755 Chorioamnionitis LLT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10041093 Small for gestational age LLT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10067508 Low birth weight baby PT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10067509 Very low birth weight baby LLT
    21.1 10036585 - Pregnancy, puerperium and perinatal conditions 10074164 Extremely low birth weight baby LLT
    20.1 10018065 - General disorders and administration site conditions 10011912 Death neonatal PT
    25.0 10042613 - Surgical and medical procedures 10086969 Medically induced preterm birth PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Female
    Trial protocol: FI (Completed) BE (Completed) DE (Completed) FR (Ongoing) ES (Completed)
    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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