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)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institute Of Tropical Medicine

Participant type

Pediatric, Healthy volunteers

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

8 Jan 2025 → ongoing

Decision date (initial)

2024-10-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

To estimate the pain intensity experienced by the child after each vaccination.

Secondary objectives 7

1. To estimate the parent’s/legal guardian’s perception of the pain intensity experienced by their child after each vaccination.
2. To assess the usability of all 3 injection methods. Different usability parameters divided in 2 categories (‘ease of use’ and ‘safety’) will be assessed by the vaccinators after each vaccination visit via a questionnaire.
3. To assess the serological response 28 days after the completion of the 31 ID rabies PrEP study schedule.
4. To describe the overall occurrence and duration of solicited and unsolicited adverse events (AEs) up to day 7 after each vaccination.
5. To describe the overall occurrence of related and unrelated medically attended adverse events (MAAEs) resulting in study discontinuation and serious adverse events (SAEs) throughout the study.
6. To estimate the anxiety experienced by the child after each vaccination.
7. 3. To estimate the parent’s/legal guardian’s perception of the anxiety experienced by their child after each vaccination.

Conditions and MedDRA coding

rabies pre-exposure prophylaxis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Age ≥ 4 and ≤ 14 years at time of informed consent
2. 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
3. Preparedness to follow the study schedule
4. 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 8

1. Any vaccination against rabies (memorised or stated in the vaccination certificate)
2. 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
3. History of extreme fear for injections, to this extent that it would be impossible to safely and child-friendly administer the study vaccine
4. History of anaphylaxis or severe allergic reaction to any vaccine or known allergy to one of the components of the study vaccine
5. Immunocompromised participants or participants who take immunosuppressive medication
6. Known coagulation disorder contra-indicating intramuscular vaccinations
7. History of or planned vaccination with an inactivated or live attenuated vaccine ≤ 14 days prior to or ≥ 14 days after each trial vaccination
8. Participation in another investigational study at the time of informed consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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

Secondary endpoints 7

1. The mean and median score of a Numeric Rating Scale (NRS), as judged by the parent/legal guardian after each vaccination.
2. The mean and median score of a NRS for each aspect of the usability parameters ‘ease of use’ and ‘safety’.
3. 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.
4. Count and percentage of solicited and unsolicited AEs up to day 7 after each vaccination. Categories: mild, moderate, severe.
5. Count and percentage of related and unrelated MAAEs resulting in study discontinuation and SAEs throughout the study period.
6. The mean and median score of the Children’s Fear Score (CFS) after each vaccination.
7. The mean and median score of a Numeric Rating Scale (NRS), as judged by the parent/legal guardian after each vaccination.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institute Of Tropical Medicine

Sponsor organisation

Institute Of Tropical Medicine

Address

Nationalestraat 155

City

Antwerp

Postcode

2000

Country

Belgium

Scientific contact point

Organisation

Institute Of Tropical Medicine

Contact name

Patrick Soentjens

Public contact point

Organisation

Institute Of Tropical Medicine

Contact name

Patrick Soentjens

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 35 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications