Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
155
Countries
1
Sites
1
Healthy infants receiving a profylactic vaccine to prevent measles infection
The main objective is to assess the immune response to MMR-0 immunisation given to infants younger than 12 months of age in a measles outbreak setting.
Key facts
- Sponsor
- Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Participant type
- Pediatric, Healthy volunteers
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Immune system processes [G12], Health Care [N] - Environment and Public Health [N06], Diseases [C] - Virus Diseases [C02]
- Decision date (initial)
- 2024-07-22
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Dutch Ministry of Health, Welfare and Sport
External identifiers
- EU CT number
- 2024-513395-18-00
- ISRCTN
- ISRCTN61052983
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
The main objective is to assess the immune response to MMR-0 immunisation given to infants younger than 12 months of age in a measles outbreak setting.
Secondary objectives 5
- Determine the presence of maternal antibodies before MMR-0 immunisation and the effect of maternal antibodies on the immune response to MMR-0 immunisation.
- Determine the measles virus specific immune response to MMR-1 immunisation and the effect of MMR-0 immunisation on this response.
- Assess MMR vaccination induced reactogenicity after MMR‐0 and MMR‐1 as an indication for vaccine responsiveness.
- Determine the immunogenicity of MMR‐0 immunisation against measles, mumps and rubella.
- Determine the effect of age at primary MMR immunisation on the immune cell phenotypic change and immune biomarkers 1 week after primary MMR immunisation (MMR-0 for the MMR-0 immunised children and MMR-1 for the control group).
Conditions and MedDRA coding
Healthy infants receiving a profylactic vaccine to prevent measles infection
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | MMR-0 immunisation Early extra MMR immunisation of infants between 6 and 12 months of age
|
Not Applicable | None | MMR-0 immunised infants: Infants who are immunised with an early extra MMR immunisation between 6 and 12 monhts of age | |
| 2 | MMR-1 immunisation Regular MMR-1 immunisation of infants at 14 months of age as part of the Dutch National Immunisation Programme
|
Not Applicable | None | MMR-0 immunised children: Children who are immunised with an early extra MMR immunisation between 6 and 12 months of age Control: Children who have not received an early extra MMR immunisation and will receive the regular MMR immunisation at 14 months of age within the Dutch National Immunisation Programme. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Infants eligible for an MMR-0 immunisation and willing to receive the MMR-0 immunisation or having received the MMR-0 immunisation less than 4 weeks ago (MMR-0 group only)
- Infants willing to receive the MMR-1 immunisation at 14 months of age (control group)
- Infants have to be healthy according to the same health criteria applied in the well baby clinic when a child is immunised, e.g. also children with small increases in body temperature or a cold are seen as children with normal health
- The parents/legally representatives accept participation in the study according to the described procedures
- Presence of a signed informed consent (the parents/legally representatives have given digital informed consent after receiving oral and written information)
Exclusion criteria 6
- Having received a previous MMR immunisation (control group only)
- Confirmed measles infection before study entry
- Contra-indications as mentioned in the SmPC of the vaccine, such as expected allergy or hypersensitivity against one of the vaccine ingredients.
- Receiving immunosuppressive medication
- Known or suspected immunological disorder
- Known or suspected bleeding disorder
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Measles specific virus neutralising antibody concentrations 4 weeks post MMR-0 immunisation
Secondary endpoints 5
- Measles specific maternal antibody concentrations prior to MMR-0 immunisation.
- Measles specific virus neutralising antibody concentrations prior to, 4 weeks post and 1 year post MMR-1 immunisation in MMR-0 immunised children and a control group.
- Assess MMR vaccination induced reactogenicity after MMR‐0 and MMR‐1 as an indication for vaccine responsiveness.
- Serum binding IgG antibody concentrations against measles, mumps and rubella prior to and 4 weeks post MMR-0 and prior to, 4 weeks post and 1 year post MMR-1 in MMR-0 immunised children and a control group.
- Immune cell phenotype and inflammation biomarkers (TruCount analysis) and immune biomarker (immune response and inflammation Olink panel) prior to and 1 week post primary MMR immunisation (MMR-0 for the MMR-0 immunised children and MMR-1 for the control group).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD4577962 · Product
- Active substance
- Rubella Virus Wistar Ra 27/3 Strain (Live, Attenuated) Produced in WI-38 Human Diploid Lung Fibroblasts
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 0.5 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BD52 — MORBILLI, COMBINATIONS WITH PAROTITIS AND RUBELLA, LIVE ATTENUATED
- Marketing authorisation
- EU/1/06/337/006
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
PRD6527260 · Product
- Active substance
- N. Meningitidis Group C (Strain C11) Polysaccharide (De-O-Acetylated) Conjugated to Tetanus Toxoid
- Substance synonyms
- MENINGOCOCCAL GROUP C CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE), NEISSERIA MENINGITIDIS GROUP C POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 0.5 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07AH08 — -
- Marketing authorisation
- EU/1/12/767/002
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Sponsor organisation
- Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Address
- Antonie Van Leeuwenhoeklaan 9
- City
- Bilthoven
- Postcode
- 3721 MA
- Country
- Netherlands
Scientific contact point
- Organisation
- Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Contact name
- INFO RIVM
Public contact point
- Organisation
- Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Contact name
- INFO RIVM
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 155 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
IIV/KIM, Antonie Van Leeuwenhoeklaan 9, 3721 MA, Bilthoven
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 |
|---|---|---|---|---|---|
| Netherlands |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-513395-18_Redacted | 4.0 |
| Protocol (for publication) | D4_Patient facing material_Diary | 1 |
| Protocol (for publication) | D4_Patient facing material_Questionnaires control group | 2 |
| Protocol (for publication) | D4_Patient facing material_Questionnaires MMR-0 group | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Aanmeldformulier ELMO onderzoek | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Tekst wervingsflyer BMR-0 groep | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Tekst wervingsflyer controlegroep | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Website tekst ELMO | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF BMR-0 groep geen huisbezoek met rijkslogo | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF BMR-0 groep met rijkslogo | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF controlegroep geen huisbezoek met rijkslogo | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF controlegroep met rijkslogo | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC M-M-RvaxPro | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MS NL 2024-513395-18 | 3.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-14 | Netherlands | Acceptable with conditions 2024-07-18
|
2024-07-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-04-29 | Netherlands | Acceptable 2026-06-10
|
2026-06-11 |