Measles virus (Edmonston-Enders), Mumps virus (Jeryl Lynn), Rubella virus (Wistar RA 27/3) (live, attenuated) for Measles

Inclusion criteria

• {"criterion_text":"- 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)"}
• {"criterion_text":"- Infants willing to receive the MMR-1 immunisation at 14 months of age (control group)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- The parents/legally representatives accept participation in the study according to the described procedures"}
• {"criterion_text":"- Presence of a signed informed consent (the parents/legally representatives have given written informed consent after receiving oral and written information)"}

Exclusion criteria

• {"criterion_text":"- Having received a previous MMR immunisation (control group only)"}
• {"criterion_text":"- Confirmed measles infection before study entry"}
• {"criterion_text":"- Contra-indications as mentioned in the SmPC of the vaccine, such as expected allergy or hypersensitivity against one of the vaccine ingredients."}
• {"criterion_text":"- Receiving immunosuppressive medication"}
• {"criterion_text":"- Known or suspected immunological disorder"}
• {"criterion_text":"- Known or suspected bleeding disorder"}

Primary endpoints

• {"endpoint_text":"- Measles specific virus neutralising antibody concentrations 4 weeks post MMR-0 immunisation","definition_or_measurement_approach":"Measured as measles-specific virus neutralising antibody concentrations assessed 4 weeks after MMR-0 immunisation."}

Secondary endpoints

• {"endpoint_text":"- Measles specific maternal antibody concentrations prior to MMR-0 immunisation.","definition_or_measurement_approach":"Measured as measles-specific maternal antibody concentrations prior to MMR-0 immunisation."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured as measles-specific virus neutralising antibody concentrations at pre-specified timepoints: prior to, 4 weeks post and 1 year post MMR-1 immunisation in both MMR-0 immunised children and control group."}
• {"endpoint_text":"- Assess MMR vaccination induced reactogenicity after MMR‐0 and MMR‐1 as an indication for vaccine responsiveness.","definition_or_measurement_approach":"Assessment of reactogenicity following MMR-0 and MMR-1 immunisations as an indicator of vaccine responsiveness (as recorded post-vaccination)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured serum binding IgG antibody concentrations against measles, mumps and rubella at specified timepoints: prior to and 4 weeks post MMR-0, and prior to, 4 weeks post and 1 year post MMR-1 in both MMR-0 immunised children and control group."}

Netherlands

Earliest CTIS Part Ii Submission Date

09-07-2024

Latest Decision Or Authorization Date

22-07-2024

Processing Time Days

13

Number Of Sites

1

Number Of Participants

155

Primary sponsor

Full Name

Rijksinstituut voor Volksgezondheid en Milieu (RIVM)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands