SYF2290b7fe8aff4e76a0687215fa05acf5Registry ID: 2024-515122-89-00|Unknown
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interventional
N/A
1 country
1
To estimate the pain intensity experienced by the child after each vaccination.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 6, 2024
Actual (reported)The mean and median score of the Faces Pain Scale-Revised (FPS-R) after each vaccination. The FPS-R is a validated scoring system for the assessment of acute pain in children from 4 years onwards
The mean and median score of a Numeric Rating Scale (NRS), as judged by the parent/legal guardian after each vaccination.
The mean and median score of a NRS for each aspect of the usability parameters ‘ease of use’ and ‘safety’.
Percentage of participants that have rabies antibodies ≥ 0.5 IU/ml on day 28 after the third dose of study vaccine. A titre ≥ 0.5 IU/ml is defined as an adequate seroconversion after vaccination according to WHO standard.
Count and percentage of solicited and unsolicited AEs up to day 7 after each vaccination. Categories: mild, moderate, severe.
Count and percentage of related and unrelated MAAEs resulting in study discontinuation and SAEs throughout the study period.
Institute Of Tropical Medicine
Antwerp, 2000, Belgium
Patrick Soentjens
First Submitted
August 6, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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