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An open-label pilot study to assess pain experience and usability of different injection techniques and devices for the administration of the purified chick-embryo cell-culture rabies vaccine in children aged 4 to 14 years (The RABIKID pilot study)
EU CTIS ID: 2024-515122-89-00
What this study is testing
To estimate the pain intensity experienced by the child after each vaccination.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 4 and ≤ 14 years at time of informed consent
- 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
- Preparedness to follow the study schedule
- 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.
You likely can't join if
- Any vaccination against rabies (memorised or stated in the vaccination certificate)
- 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
- History of extreme fear for injections, to this extent that it would be impossible to safely and child-friendly administer the study vaccine
- History of anaphylaxis or severe allergic reaction to any vaccine or known allergy to one of the components of the study vaccine
- Immunocompromised participants or participants who take immunosuppressive medication
- Known coagulation disorder contra-indicating intramuscular vaccinations
See the full eligibility criteria
- Age ≥ 4 and ≤ 14 years at time of informed consent
- 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
- Preparedness to follow the study schedule
- 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.
- Any vaccination against rabies (memorised or stated in the vaccination certificate)
- 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
- History of extreme fear for injections, to this extent that it would be impossible to safely and child-friendly administer the study vaccine
- History of anaphylaxis or severe allergic reaction to any vaccine or known allergy to one of the components of the study vaccine
- Immunocompromised participants or participants who take immunosuppressive medication
- Known coagulation disorder contra-indicating intramuscular vaccinations
- History of or planned vaccination with an inactivated or live attenuated vaccine ≤ 14 days prior to or ≥ 14 days after each trial vaccination
- Participation in another investigational study at the time of informed consent
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.