Study on Pain and Usability of Rabies Vaccine Injection Techniques in Children Aged 4-14 Using Inactivated Rabies Virus (Strain Flury LEP)

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What is this study about?

This clinical trial is focused on studying the experience of pain and the ease of use of different injection techniques and devices for administering a vaccine against rabies in children aged 4 to 14 years. Rabies is a serious disease caused by a virus that affects the brain and can be fatal if not treated promptly. The vaccine used in this study is called Rabipur, which contains an inactivated form of the rabies virus to help the body build protection against the disease.

The purpose of the study is to estimate the level of pain children feel after receiving the vaccine. The study will involve giving the vaccine using different methods, such as injecting it into the skin (intradermal) or into the muscle (intramuscular). The study will also look at how easy and safe these methods are to use. Children participating in the study will receive the vaccine and their pain levels will be measured using a special scale designed for children. Parents or guardians will also provide their observations on the child’s pain and the usability of the injection methods.

The study will monitor the children for any side effects after the vaccination and will check if the vaccine successfully helps the body produce enough antibodies to protect against rabies. The study aims to provide valuable information on the best ways to administer the rabies vaccine to children, ensuring both effectiveness and comfort.

1 joining the study

Upon joining the study, the child must be between the ages of 4 and 14. A parent or legal guardian must provide written consent, confirming that both parents or guardians are aware of and agree to the child’s participation.

The child should be prepared to follow the study schedule, which includes multiple visits for vaccinations. The study is designed for children who are expected to travel to areas where rabies is common, and there is a high risk of exposure.

2 first vaccination

The child will receive the first dose of the rabies vaccine, which is a solution for injection. The vaccine is administered using different techniques, either intradermal (into the skin) or intramuscular (into the muscle).

After the vaccination, the child’s pain experience will be assessed using the Faces Pain Scale-Revised (FPS-R), a tool to measure pain in children. The parent or guardian will also provide feedback using a Numeric Rating Scale (NRS).

3 second vaccination

The child will return for a second dose of the rabies vaccine. The administration technique may vary as part of the study’s assessment of different methods.

Pain and usability will again be evaluated using the FPS-R and NRS. The child’s fear level will also be measured using the Children’s Fear Score (CFS).

4 third vaccination

The third dose of the rabies vaccine will be administered. The study continues to assess pain, usability, and fear using the same scales as before.

On day 28 after the third dose, a blood test will be conducted to measure the level of rabies antibodies. A level of 0.5 IU/ml or higher is considered adequate according to the World Health Organization (WHO) standards.

5 monitoring and follow-up

The child will be monitored for any side effects up to 7 days after each vaccination. Side effects are categorized as mild, moderate, or severe.

Throughout the study, any significant medical events will be recorded, and the study may be discontinued if necessary. The study is expected to end by December 31, 2025.

Who Can Join the Study?

Child’s age must be between 4 and 14 years at the time of giving consent to participate.
A parent or legal guardian must be willing to provide written consent, confirming that the other parent or guardian is aware of and agrees with the child’s participation in the trial.
The child and their family must be prepared to follow the study schedule.
The child is expected to travel to one or more countries where rabies is common, and there is a high risk of exposure, making it necessary to receive rabies pre-exposure prophylaxis (PrEP).

Who Cannot Join the Study?

Children who are not in the age range of 2 years old cannot participate.
Children who have any medical condition other than rabies pre-exposure prophylaxis cannot participate. Rabies pre-exposure prophylaxis means receiving a vaccine to prevent rabies before being exposed to the virus.
Children who are not able to receive vaccinations cannot participate.
Children who are part of a vulnerable population, which means they need special protection or care, cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Institute Of Tropical Medicine	Antwerp	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	06.01.2025

Trial locations

Purified Chick-Embryo Cell-Culture Rabies Vaccine is a vaccine used to protect against rabies, a serious disease caused by a virus that affects the brain. This vaccine is made using cells from chick embryos, which helps to produce a safe and effective way to prevent rabies. In this study, the vaccine is given to children to see how they feel after getting the shot and to find out which way of giving the shot is the most comfortable for them. The goal is to make sure that children experience as little pain as possible when they receive their rabies vaccination.

Investigated diseases:

Rabies

Rabies – Rabies is a viral disease that affects the central nervous system. It is primarily transmitted through the bite of an infected animal. The virus travels from the site of the bite through the nerves to the brain, where it causes inflammation. Initial symptoms may include fever, headache, and general weakness. As the disease progresses, neurological symptoms such as anxiety, confusion, and agitation may develop. Eventually, the disease can lead to paralysis and other severe neurological complications.

Trial ID:

2024-515122-89-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Pain and Usability of Rabies Vaccine Injection Techniques in Children Aged 4-14 Using Inactivated Rabies Virus (Strain Flury LEP)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?