Overview
Sponsor-declared trial summary
Pediatric cancer
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…
Key facts
- Sponsor
- Vaestra Goetalandsregionen
- Participant type
- Pediatric, Patients, Healthy volunteers
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 22 May 2025 → ongoing
- Decision date (initial)
- 2024-09-27
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
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).
Secondary objectives 3
- Percentage of patients losing immunity to chickenpox and measles after cancer treatment (Percentage (%) of immune patients before treatment - Percentage (%) of immune patients after treatment).
- Changes in cellmediated immunity against varicella and measles during treatment and after revaccination. Comparisons will be made with a healthy control group
- Subgroup analyses: Differences in antibody levels and cellmediated immunity between various diagnostic groups (leukemia/solid tumor), different age groups, low- vs. high-intensity treatment, and pre-immune versus non-immune groups at specific time points.
Conditions and MedDRA coding
Pediatric cancer
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-511182-10-00 | 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. | Vaestra Goetalandsregionen |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 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 criteria 6
- Known primary immunodeficiency.
- 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.
- Female participants with an ongoing pregnancy at diagnosis or during the study
- Ongoing breastfeeding.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Difference in VZ IgG antibody levels before and after revaccination against chickenpox
- Difference in measles IgG antibody level before and after revaccination against measles
Secondary endpoints 3
- Percentage of patients with immunity against chickenpox and measles before and after treatment measured in IgG
- Changes in cellmediated immunity (CMI) against chickenpox and measles before and after revaccination. Comparisons with a healthy control group.
- Differences in antibody levels and CMI between various diagnostic groups (leukemias, solid tumors), different age groups, low- vs. high-intensity treatment, and pre-immune versus non-immune groups
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Varicella Virus Oka Strain (Live, Attenuated)
SCP26852943 · ATC
- Active substance
- Varicella Virus Oka Strain (Live, Attenuated)
- Substance synonyms
- VARICELLA VIRUS, STRAIN OKA, LIVE ATTENUATED, ATTENUATED LIVE VARICELLA - ZOSTER VIRUS (OKA STRAIN)
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1.0 ml millilitre(s)
- Max treatment duration
- 2 Month(s)
- Authorisation status
- Authorised
- ATC code
- J07BK01 — VARICELLA, LIVE ATTENUATED
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Measles Virus Edmonston-Schwarz Strain (Live, Attenuated) Produced in Chick Embryo Cells
SCP26553389 · ATC
- Active substance
- Measles Virus Edmonston-Schwarz Strain (Live, Attenuated) Produced in Chick Embryo Cells
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1.0 ml millilitre(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- J07BD52 — MEASLES, COMBINATIONS WITH MUMPS AND RUBELLA, LIVE ATTENUATED
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vaestra Goetalandsregionen
- Sponsor organisation
- Vaestra Goetalandsregionen
- Address
- Regionens Hus
- City
- Vänersborg
- Postcode
- 462 80
- Country
- Sweden
Scientific contact point
- Organisation
- Vaestra Goetalandsregionen
- Contact name
- Torben Ek
Public contact point
- Organisation
- Vaestra Goetalandsregionen
- Contact name
- Torben Ek
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 160 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2025-05-22 | 2025-06-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-511182-10-00 | 1.1 |
| Recruitment arrangements (for publication) | K1_rekryteringsforfarande_2024-511182-10-00 | 1 |
| Subject information and informed consent form (for publication) | L1_Forsokpersonsinformation_2024-511182_10-00_12-14ar | 1.1 |
| Subject information and informed consent form (for publication) | L1_Forsokpersonsinformation_samtycken_2024-511182-10-00_15-18ar | 1.1 |
| Subject information and informed consent form (for publication) | L1_Forsokpersonsinformation_samtycken_2024-511182-10-00_vardnadshavare | 1.1 |
| Subject information and informed consent form (for publication) | L1_Forsokpersonsinformaton_2024-511182-10-00_6-11ar | 1.1 |
| Subject information and informed consent form (for publication) | L1_Forsokspersonsinformation_2024-511182-10-00_12-14ar_friska | 1.1 |
| Subject information and informed consent form (for publication) | L1_Forsokspersonsinformation_2024-511182-10-00_6-11ar_friska | 1.1 |
| Subject information and informed consent form (for publication) | L1_Forsokspersonsinformation_samtycke_2024-511182-10-00_15-18ar_friska | 1.1 |
| Subject information and informed consent form (for publication) | L1_Forsokspersonsinformation_samtycke_2024-511182-10-00_vard_friska | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_M-M-RVAXPRO | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_varivax | 1 |
| Synopsis of the protocol (for publication) | D2_Protocol_synopsis_SE_2024-511182-10-00 | 1.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-18 | Sweden | Acceptable 2024-09-26
|
2024-09-27 |