EarLy extra Measles immunisation during a measles Outbreak (ELMO)

Phase 1

• Conditions: Healthy infants receiving a profylactic vaccine to prevent measles infection; Therapeutic area: Health Care [N] - Environment and Public Health [N06]; Therapeutic area: Phenomena and Processes [G] - Immune system processes [G12]; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: CTIS2024-513395-18-00
• Lead Sponsor: Rijksinstituut voor Volksgezondheid en Milieu (RIVM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-14
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

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 written informed consent after receiving oral and written information)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 Objective: 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.;Primary end point(s): Measles specific virus neutralising antibody concentrations 4 weeks post MMR-0 immunisation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Measles specific maternal antibody concentrations prior to MMR-0 immunisation.;Secondary end point(s):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.;Secondary end point(s):Assess MMR vaccination induced reactogenicity after MMR-0 and MMR-1 as an indication for vaccine responsiveness.;Secondary end point(s):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.