Early extra measles immunisation during a measles outbreak

EarLy extra Measles immunisation during a measles Outbreak

Registry ID
ISRCTN61052983
Source registry
ISRCTN
Status
Recruiting
Phase
PHASE4
Study type
INTERVENTIONAL
Sponsor
National Institute for Public Health and the Environment
Enrollment
155
Start date
2026-08-01
Completion date
2028-12-31
Last update
2026-08-17

Conditions

Summary

Measles infection in children

Detailed description

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. Optionally, five or three venepunctures of 4 ml per sampling time point are performed, respectively, if parents decide to participate in the cellular immunity part of this study. To gain a better insight in the maternal antibodies in the child, the biological mothers of MMR-0 immunised children will be asked for an optional blood sample by fingerstick of 300-800 µl.

Interventions

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

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

Locations

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