VAC4EU Postauthorisation Safety Study of BIMERVAX® Vaccine in Europe

21/10/2024
04/08/2026
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

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Updated protocol

Protocol_PASS_6578_HIPRA_BIMERVAX_V3.0_Final_16Oct2025_Redacted.pdf

First published: 12/02/2026
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Protocol_PASS_6578_HIPRA_BIMERVAX_V2.0_12March2025_redacted.pdf

First published: 25/11/2025
English (1.52 MB - PDF) View document
Study results
No information provided.
Study report
No information provided.
Other information
Study, other information

Bimervax PASS_DeclarationofInterests-Annex5_XGA.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_VR.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_SR.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_SPG.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_SB.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_R Gini.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_Paoletti.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_PAB.pdf

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Bimervax PASS_Declarationofinterests-Annex5_MS.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_Miller.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_MFR.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_M Soriano Gabarro 27 Jan 2026.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_LG.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_KB.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_JVG.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_JR.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_JMSG.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_JJCM.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_JD.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_JBL.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_GS.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_G Roberto.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_FV.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_EVC.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_EP.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_ECM.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_DM.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_Davide_Messina.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_CR.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_BPP.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_ASM_signed_ASM.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_Arantxa Urchueguía.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_AGM.pdf

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Bimervax PASS_DeclarationofInterests-Annex5_A Girardi.pdf

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Bimervax PASS_DeclarationofInterests-Annex5 VAC4EU Daniel Weibel.pdf

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ENCePP Seal
Conflicts of interest of investigators

01_DeclarationofInterests-Annex5 - signed.pdf

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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

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