Overview
Sponsor-declared trial summary
Prevention of measles, mumps, and rubella by vaccination
The follow-up study has one primary aim: To measure the level of specific immunity, measured as level of measles neutralising antibodies by plaque-reduction neutralisation test 1-3 years after routine MMR vaccination at 4 years of age and compare this level between the two original MMR groups: The one, which received a…
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Pediatric, Healthy volunteers
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Decision date (initial)
- 2026-06-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Efficacy
The follow-up study has one primary aim:
To measure the level of specific immunity, measured as level of measles neutralising antibodies by plaque-reduction neutralisation test 1-3 years after routine MMR vaccination at 4 years of age and compare this level between the two original MMR groups: The one, which received an early MMR and the one, which received placebo in the trial .
Secondary objectives 1
- • Level of specific immunity, measured as level of measles neutralising antibodies by plaque-reduction neutralisation test at least 1 year after MMR2. • Level of specific immunity, measured as level of IgG against measles at least 1 year after MMR2. • Level of specific immunity, measured as level of IgG against measles at baseline (in the original trial, if we have that information) will be taken into consideration when reporting this secondary outcome. • IgG against mumps and rubella at least 1 year after MMR2. Level of specific immunity, measured as level of IgG against mumps and rubella at baseline will be taken into consideration when reporting these secondary outcomes. • The associations between level of maternal specific immunity against measles, mumps and rubella and the child’s specific immunity against measles, mumps and rubella will be studied. • Influence of mother’s birth year (before 1986, between 1986-87 or after 1987) as a proxy for maternal immunization status will be studied as well. • The decay rate between two sampling time points will be calculated for those individuals, who we collect consecutive samples from.
Conditions and MedDRA coding
Prevention of measles, mumps, and rubella by vaccination
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Participation in the original MMR trial
Exclusion criteria 1
- Immune-deficiency (primary or acquired) or –suppression, and/or intake of immune modulating medicine (including high doses of corticosteroids), thrombocytopenia or any coagulation disorder, blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems. Children who received blood or plasma transfusions, or administration of human immune serum globulin within the last 3 months will be excluded.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To measure the level of specific immunity, measured as level of measles neutralising antibodies by plaque-reduction neutralisation test 1-3 years after routine MMR vaccination at 4 years of age
Secondary endpoints 1
- • Level of specific immunity, measured as level of measles neutralising antibodies by plaque-reduction neutralisation test at least 1 year after MMR2. Level of specific immunity, measured as level of IgG against measles, mumps, and rubella at least 1 year after MMR2.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP124970547 · ATC
- Active substance
- Mumps Virus Rit 4385 Strain (Live, Attenuated) Derived From From the Jeryl Lynn Produced in Chick Embryo Cells
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 3 ml millilitre(s)
- Max treatment duration
- 1 Day(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
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Dorthe Maria Vittrup
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Dorthe Maria Vittrup
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Region Hovedstaden ORG-100003705
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 1,000 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol MMR trial follow-up | 3 |
| Recruitment arrangements (for publication) | Appendix 1 Invitationsemail_v1 | 1 |
| Recruitment arrangements (for publication) | informedconsent_patientrecruitmentprocedure_MMR | 1 |
| Subject information and informed consent form (for publication) | Appendix 2 Deltagerinformation_v1_underskrevet | 3 |
| Subject information and informed consent form (for publication) | Appendix 3 Samtykkeerklring S6_v1 | 2 |
| Subject information and informed consent form (for publication) | Appendix 5 Deltagerinformation_barn_v1_24032026 | 3 |
| Subject information and informed consent form (for publication) | Appendix 6 fuldmagt-foraeldremyndighedsindehavere | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | m-m-rvaxpro-epar-product-information_da_12042019 | 1 |
| Synopsis of the protocol (for publication) | Protokolresume | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-12 | Denmark | Acceptable 2026-06-02
|
2026-06-08 |