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ID
Source
Brief title
Health condition
Measles infection, paramyxovirus
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the effect of early extra measles immunization on the humoral immunity against measles 6 years after
MMR-1 at 14 months of age
Secondary outcome
•Determine the effect of early extra measles immunization on the immunity against mumps and rubella 6 years after
MMR-1 at 14 months of age
•Determine the effect of early extra measles immunization on the immunity against other NIP vaccines 6 years after
MMR-1 at 14 months of age
Background summary
From May 2013 until March 2014, a measles epidemic occurred in the Netherlands. During this epidemic, the Dutch
Ministry of Health decided to offer infants between 6 and 12 months of age, living in the measles outbreak area, an
early extra MMR (MMR-0) immunization. We previously investigated the immunological response to early vaccination
in a cohort of these children up to 4 years of age (NL45616.094.13/IIV-273). The first outcome was that all children who
received an early extra MMR-0 vaccination between 6-12 months of age showed a measles antibody response. A large
part of these children had protective measles levels (≤0.12 IU/ml) at the age of 14 months. These children were
protected during the measles epidemic. After the regular MMR-1 vaccination at 14 months of age, almost all children
had protective levels (both in the early extra MMR-0 group as in the regular MMR-1 group). Three years later in part of
the early extra MMR-0 vaccinated children measles antibody levels dropped below the protective threshold, while all
regular MMR-1 vaccinated children still had protective measles levels. This steeper decline of measles antibody levels
will be monitored in the current study. We will measure further decline in measles specific (functional) antibody
concentration and the proportion of children with antibodies below the cut-off for clinical protection 6 years after the
MMR-1 vaccination.
Study objective
We will measure further decline in measles specific (functional) antibody concentration and the proportion of children with antibodies below the cut-off for clinical protection 6 years after the
MMR-1 vaccination.
Study design
6 years post MMR-1
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Participation in the study on the immunological effects of early measles vaccination, as described in a separate study protocol (NL45616.094.13/IIV-273)
• The parents/legally representatives accept participation in the trial according to the described procedures
• Presence of a signed informed consent
• Children must have received their NIP vaccinations according to schedule.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Receiving immunosuppressive medication
• Presence of a serious disease that requires medical care that can interfere with the results of the study
• Known or suspected immunological disorder
• Bleeding disorders
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8035 |
| CCMO | NL69434.100.19 |
| OMON | NL-OMON48447 |