A 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 (Peuterprik)

First published 05/03/2014

Last updated 02/07/2024

EU PAS number:

EUPAS5937

Study

Finalised

Documents

Study protocol

Initial protocol

Study Protocol Peuterprik-Version1.2-15jan14

English (283.87 KB - PDF)View document

Updated protocol

Study Protocol Peuterprik-Version1 4-Amendment2-21JUL2015

First published: 22/02/2024

English (698.64 KB - PDF)View document

Study results

PP NeisVacC Study Report Final version 1-1AUG2016

English (730.17 KB - PDF)View document

SUMMARY PP NeisVacC Study Final version 1-1AUG2016

English (248.51 KB - PDF)View document

Study report

Other information

ENCePP Seal

This study has been awarded the ENCePP seal

ENCePP Seal documents

Conflicts of interest of investigators

Declaration of interest-signed-24FEB14

English (460.31 KB - PDF)View document

Composition of steering group and observers

Steering Group and Observers Peuterprik onderzoek-5MAR14

English (4.63 KB - PDF)View document

Signed code of conduct

Annex 3 signed-24FEB14

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Signed code of conduct checklist

Annex 2 signed 12Mar2014 (1)

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Signed checklist for study protocols

Checklist for Study Protocol signed-24FEB14

English (651.11 KB - PDF)View document

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