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Taking people in Svédország4. fázis

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.

Key facts

Where
Boras, Gothenburg, Halmstad, Jonkoping, Karlstad, Skovde és Trollhattan, SvédországSee the 7 sites
Phase
4. fázis

Where in Svédország

  • Sodra Alvsborg Hospital-Vastra GotalandsregionenBoras, SvédországTaking people
  • Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vastra GotalandsregionenGothenburg, SvédországTaking people
  • Region HallandHalmstad, SvédországTaking people
  • Region Joenkoepings LaenJonkoping, SvédországTaking people
  • Region VaermlandKarlstad, SvédországTaking people
  • Skaraborg Hospital-Vastra GotalandsregionenSkovde, SvédországTaking people
  • NU Hospital Group-Vastra GotalandsregionenTrollhattan, SvédországTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Vaestra Goetalandsregionen
Trial code
EU 2024-511182-10-01
Record updated
2024. szeptember 27.
Original description
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).Read full original descriptionShow less

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).

Inclusion: 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).

Exclusion: 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; Known primary immunodeficiency; Female participants with an ongoing pregnancy at diagnosis or during the study; Ongoing breastfeeding.

EU CTIS 2024-511182-10-01