RABIES VIRUS (INACTIVATED) STRAIN FLURY LEP for Rabies (pre-exposure prophylaxis)

Inclusion criteria

• {"criterion_text":"- Age ≥ 4 and ≤ 14 years at time of informed consent\n- Parent/legal guardian is willing to provide written informed consent, thereby confirming the other parent/legal guardian is aware of the trial and agrees with the child’s participation\n- Preparedness to follow the study schedule\n- One or more expected travel(s) to (a) rabies endemic countr(y)(ies), for which the (cumulative) risk is evaluated as high for rabies exposure and therefore is an indication to receive rabies PrEP."}

Exclusion criteria

• {"criterion_text":"- Any vaccination against rabies (memorised or stated in the vaccination certificate)\n- Any planned travel from the day of screening until 15 days after receiving the third dose of the study vaccine to rabies endemic countries which is evaluated as high risk for rabies exposure and therefore is an indication to receive standard rabies PrEP\n- History of extreme fear for injections, to this extent that it would be impossible to safely and child-friendly administer the study vaccine\n- History of anaphylaxis or severe allergic reaction to any vaccine or known allergy to one of the components of the study vaccine\n- Immunocompromised participants or participants who take immunosuppressive medication\n- Known coagulation disorder contra-indicating intramuscular vaccinations\n- History of or planned vaccination with an inactivated or live attenuated vaccine ≤ 14 days prior to or ≥ 14 days after each trial vaccination\n- Participation in another investigational study at the time of informed consent"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Measured using the Faces Pain Scale-Revised (FPS-R); the FPS-R is a validated scoring system for assessment of acute pain in children from 4 years onwards. Mean and median FPS-R scores will be calculated after each vaccination."}

Secondary endpoints

• {"endpoint_text":"- The mean and median score of a Numeric Rating Scale (NRS), as judged by the parent/legal guardian after each vaccination.\n- The mean and median score of a NRS for each aspect of the usability parameters ‘ease of use’ and ‘safety’.\n- 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.\n- Count and percentage of solicited and unsolicited AEs up to day 7 after each vaccination. Categories: mild, moderate, severe.\n- Count and percentage of related and unrelated MAAEs resulting in study discontinuation and SAEs throughout the study period.\n- The mean and median score of the Children’s Fear Score (CFS) after each vaccination.\n- The mean and median score of a Numeric Rating Scale (NRS), as judged by the parent/legal guardian after each vaccination.","definition_or_measurement_approach":"NRS scores as judged by parent/legal guardian will be summarised (mean, median) after each vaccination. Usability parameters ('ease of use' and 'safety') are assessed by vaccinators via questionnaire and summarised using NRS mean/median. Serology: proportion with rabies antibody titre ≥ 0.5 IU/ml at day 28 after third dose (WHO threshold for adequate seroconversion). Safety: counts and percentages of solicited/unsolicited AEs up to day 7 after each vaccination (categorised mild/moderate/severe); counts and percentages of MAAEs and SAEs throughout study. Fear assessed by Children’s Fear Score (CFS) with mean/median reported."}

Methods

• Social media advertisements (English and Dutch) aimed at parents/legal guardians (documents listed: social media_English, social media_Dutch).
• E-mail communications from Institute of Tropical Medicine (E-mail ITM_English; E-mail ITM_Dutch) and database emails (E-mail database_English; E-mail database_Dutch) targeting potential participants/parents.
• Flyers and website information pages in Dutch and English (Flyer_Dutch, Flyer_English, Info website_Dutch, Info website_English) directed at the public and parents in Belgium.
• Direct contact via clinic/hospital channels at the Institute of Tropical Medicine (site-based recruitment).
• Recruitment arrangements and procedures document provided (L_2024-515122-89_PI informedconsent_patientrecruitmentprocedure).

Belgium

Earliest CTIS Part Ii Submission Date

30-09-2024

Latest Decision Or Authorization Date

30-04-2025

Processing Time Days

212

Number Of Sites

1

Number Of Participants

48

Primary sponsor

Full Name

Institute Of Tropical Medicine

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium