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Clinical trials for 2022-003124-41

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    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   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).

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    1 result(s) found for: 2022-003124-41. Displaying page 1 of 1.
    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 (Completed) ES (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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