VAC4EU Postauthorisation Safety Study of BIMERVAX® Vaccine in Europe

21/10/2024
22/05/2026
EU PAS number:
EUPAS1000000321
Study
Planned
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Documents
Study protocol
Initial protocol

Protocol_PASS_6578_HIPRA_BIMERVAX_Final_V1.1_12Jan2024_clean_Redacted.pdf

English (2.62 MB - PDF) View document
Updated protocol

Protocol_PASS_6578_HIPRA_BIMERVAX_V3.0_Final_16Oct2025_Redacted.pdf

First published: 12/02/2026
English (1016.97 KB - PDF) View document

Protocol_PASS_6578_HIPRA_BIMERVAX_V2.0_12March2025_redacted.pdf

First published: 25/11/2025
English (1.52 MB - PDF) View document
Study results
Study report
Other information
ENCePP Seal
Conflicts of interest of investigators

01_DeclarationofInterests-Annex5 - signed.pdf

English (245.48 KB - PDF) View document
Composition of steering group and observers

02_ENCePPCoCSteeringGroup.pdf

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Signed code of conduct

03_ENCePPCoCAnnex3_DeclarationofcompliancewiththeENCePPCodeofConduct - signed.pdf

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Signed code of conduct checklist

04_ENCePPCoCAnnex2_ChecklistofCodeofConduct - signed.pdf

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Signed checklist for study protocols

05_ENCePPChecklistforStudyProtocol - signed.pdf

English (450.08 KB - PDF) View document