Status: Finalised First registered on: 28/02/2014
Last updated on: 05/07/2017
1. Study identification
EU PAS Register NumberEUPAS5937
Official titleA non-interventional, open observational non-inferiority study in two cluster-assigned cohorts of children aged 14 months into the safety of NeisVac-C® vaccines manufactured at two different production sites and given simultaneously with measles-mumps-rubella vaccine, assessed by web-based intensive monitoring
Study title acronymPeuterprik
Study typeObservational study
Brief description of the studyNon-interventional, open observational non-inferiority study with two cluster- assigned cohorts of toddlers (14 months old) who receive at vaccination centers NeisVac-C® vaccination with either - “old” lots produced in Beltsville (group B), or - “new” lots from Orth/Donau (group A), simultaneously with MMR vaccine. Clusters are assigned at the level of vaccination centers. From 4 full days after the vaccines were administered, parents will receive web-based questionnaires with questions about any ADRs that occurred after vaccination.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsNetherlands Pharmacovigilance Centre Lareb
Department/Research group
Organisation/affiliationNetherlands Pharmacovigilance Centre Lareb
Website/Homepagewww.lareb.nl
Details of (Primary) lead investigator
Title Dr
Last name van Puijenbroek
First name Eugene
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Netherlands
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed05/12/2013
Start date of data collection01/07/201401/07/2014
Start date of data analysis30/06/201631/05/2016
Date of interim report, if expected
Date of final study report30/09/201601/08/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesPfizer Inc (formerly Baxter GmbH)100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Rumke
First name Hans C
Address line 1Goudsbloemvallei 7
Address line 2 
Address line 3 
City's-Hertogenbosch 
Postcode5237MH 
CountryNetherlands
Phone number (incl. country code)31-73-6469700 
Alternative phone number 
Fax number (incl. country code) 
Email address info@lareb.nl
Public Enquiries
Title Dr 
Last name van Puijenbroek 
First name Eugene 
Address line 1Goudsbloemvallei 7 
Address line 2 
Address line 3 
City's-Hertogenbosch 
Postcode5237MH 
CountryNetherlands 
Phone number (incl. country code)31-73-6469700 
Alternative phone number 
Fax number (incl. country code)31-73-6426136 
Email address e.vanpuijenbroek@lareb.nl 
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