Immunological effect of early extra MMR immunization in infants between 6 and 12 months of age in an outbreak setting

Immunological effect of early extra MMR immunization in infants between 6 and 12 months of age in an outbreak setting - Immunological effect of early extra MMR immunization (EMI)

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44694

Enrollment

100

Registered

2013-08-07

Start date

2013-10-08

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Measles infection paramyxovirus

Interventions

This study is designed to monitor the effects of an early extra MMR-0 immunization in children 6 to 12 months of age in a measles outbreak area, with the aim to protect these vulnerable infants agai

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Group 1: infants receiving (or having received) MMR-0 between 6-12 months of age and who are about to receive the MMR-1 at 14 months of age;Group 2: infants not receiving MMR-0 and who are about to receive the MMR-1 at 14 months of age

Exclusion criteria

Exclusion criteria: Encountered measles infection earlier in life;Receiving immunosuppressive medication;Presence of a serious disease that requires medical care that can interfere with the results of the study;Known or expected allergy/hypersensitivity against one of the vaccine ingredients;Known or suspected immunological disorder;Bleeding disorders

Design outcomes

Primary

Measure	Time frame
Measles specific B- and T-cell immunogenicity Measles specific serum IgG antibody concentrations, avidity (Luminex), and functional antibody characteristics with plaque neutralisation (PRN)	—

Secondary

Measure	Time frame
Serum IgG antibody concentrations against other vaccines of the NIP (mumps, rubella, MenC, diphtheria, tetanus, pertussis antigens (Ptx, FHA and PRN), Hib, HepB, and pneumococcal serotypes present in PCV10 (Luminex) Measles, mumps and rubella antibody concentrations in DBS collected at 6 days of age, to monitor the concentrations of maternal antibodies delivered at birth (and to predict the concentrations at the time of MMR- 0)	—

Measure

Time frame

Serum IgG antibody concentrations against other vaccines of the NIP (mumps, rubella, MenC, diphtheria, tetanus, pertussis antigens (Ptx, FHA and PRN), Hib, HepB, and pneumococcal serotypes present in PCV10 (Luminex) Measles, mumps and rubella antibody concentrations in DBS collected at 6 days of age, to monitor the concentrations of maternal antibodies delivered at birth (and to predict the concentrations at the time of MMR- 0)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)