2024-511182-10-01RecruitingPhase 4
A clinical phase IV trial to examine cellular and humoral immunity against measles and chickenpox in children and adolescents 0-18 years in childhood cancer.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 27 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Primary aim 1) Immunity after revaccination with vaccine aganist varicella, after treatment against childhood cancer. Measured by IgG antibodies to VZV before and after vaccination. (Proportion (%) of patients with protective level of VZ-IgG after vaccination – proportion (%) of patients with protective level of VZ-IgG before vaccination). 2) Immunity after revaccination with vaccine against measles, after treatment against childhood cancer. Measured by IgG antibodies to morbilli before and after vaccination. (Proportion (%) of patients with protective morbilli-IgG level after vaccination – proportion (%) of patients with protective morbilli-IgG level prior to vaccination).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 18 Jun 2024
- Start date
- 22 May 2025
- Lead sponsor
- Vaestra Goetalandsregionen
- Diseases
- Childhood cancers
- EU CT number
- 2024-511182-10-01
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 160
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ongoing treatment with immunomodulatory or immunosuppressive agents
- Patients planned for relapse therapy or stem cell transplantation (SCT)
- Known contraindication to any of the proposed vaccines.
Other
- Known primary immunodeficiency.
- Female participants with an ongoing pregnancy at diagnosis or during the study
- Ongoing breastfeeding.
Who the study is looking for
- Children and adolescents (0-18.0 years) initiating cancer treatment through the childrens cancer centre in Gothenburg.
- Vaccination status for measles and chickenpox before cancer treatment is known.
- Oral and written information about the trial along with signed consent
- Female participants of reproductive age with menarche who are sexually active must consent to using effective contraception and have a negative pregnancy test at the times of all vaccinations. (Effective contraception refers to combined preparations with estrogen and progesterone taken orally, intravaginal ring, known as the p-ring, or preparations used transdermally, such as the contraceptive patch. Contraception with progesterone taken orally, via injections, or implants such as the contraceptive implant. Intrauterine hormone-releasing coil or copper coil. Completed sterilization with blockage of both fallopian tubes. Sexual abstinence)
Age in the registry: - to 17 years · Sex: All · Accepts healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sodra Alvsborg Hospital-Vastra Gotalandsregionen Coordinator of this site? Confirm its status | Boras | Sweden | Recruiting |
| Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vastra Gotalandsregionen Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
| Region Halland Coordinator of this site? Confirm its status | Halmstad | Sweden | Recruiting |
| Region Joenkoepings Laen Coordinator of this site? Confirm its status | Jonkoping | Sweden | Recruiting |
| Region Vaermland Coordinator of this site? Confirm its status | Karlstad | Sweden | Recruiting |
| Skaraborg Hospital-Vastra Gotalandsregionen Coordinator of this site? Confirm its status | Skovde | Sweden | Recruiting |
| NU Hospital Group-Vastra Gotalandsregionen Coordinator of this site? Confirm its status | Trollhattan | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.