Study identification

PURI

https://redirect.ema.europa.eu/resource/19783

EU PAS number

EUPAS5937

Study ID

19783

Official title and acronym

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)

DARWIN EU® study

No

Study countries

Netherlands

Study description

Non-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.

Study status

Finalised
Research institution and networks

Institutions

Contact details

Eugene van Puijenbroek

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc (formerly Baxter GmbH)
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

English (698.64 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)