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Early extra measles immunisation during a measles outbreak

EarLy extra Measles immunisation during a measles Outbreak

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN61052983
Enrollment
155
Registered
2024-08-20
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Measles infection in children Infections and Infestations

Interventions

Participation in this study entails five heel- or fingerstick blood collections of 250-500 µl for the MMR-0 group and three heel- or fingerstick blood collections of 250-500 µl for the control group.

Sponsors

National Institute for Public Health and the Environment
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 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) 2. Infants willing to receive the MMR-1 immunisation at 14 months of age (control group) 3. 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 4. The parents/legally representatives accept participation in the study according to the described procedures 5. Presence of a signed informed consent (the parents/legally representatives have given written informed consent after receiving oral and written information)

Exclusion criteria

Exclusion criteria: 1. Confirmed measles infection before study entry 2. Having received an MMR immunisation (control group only) 3. Contra-indications as mentioned in the SmPC of the vaccine, such as expected allergy or hypersensitivity against one of the vaccine ingredients. 4. Receiving immunosuppressive medication 5. Known or suspected immunological disorder 6. Known or suspected bleeding disorder

Design outcomes

Primary

MeasureTime frame
Measles specific virus neutralising antibody concentrations 4 weeks mesured by blood sample post MMR-0 immunisation

Secondary

MeasureTime frame
Measured by blood sample: 1. Measles specific maternal antibody concentrations prior to MMR-0 immunisation. 2. 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. 3. Assess MMR vaccination induced reactogenicity after MMR-0 and MMR-1 as an indication for vaccine responsiveness.  4. 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.

Countries

Netherlands

Contacts

Public ContactEsther Gijsbers
elmo@rivm.nl+31 (0)886897314

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026