Early extra measles immunisation during a measles outbreak

Phase 4

• Conditions: Measles infection in children; Infections and Infestations

• Registration Number: ISRCTN61052983
• Lead Sponsor: ational Institute for Public Health and the Environment

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-20
• Last Update Posted: 2 September 2024
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 155

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measles specific virus neutralising antibody concentrations 4 weeks mesured by blood sample post MMR-0 immunisation

Secondary Outcome Measures

Name	Time	Method
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.