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Extract from Clinical Evaluation: Meningococcal Group B Vaccine

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Extract from Clinical Evaluation: Meningococcal Group B Vaccine AusPAR Attachment 2 Extract from the Clinical Evaluation Report for Records -Meningococcal group B vaccine Proprietary Product Name: Trumenba Sponsor: Pfizer Australia Pty Ltd 30 October 2016 Therapeutic Goods Administration About the Therapeutic Goods Administration (TGA) · The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating medicines and medical devices. · The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. · The work of the TGA is based on applying scientific and clinical expertise to decision- making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. · The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. · To report a problem with a medicine or medical device, please see the information on the TGA website <https://www.tga.gov.au>. About the Extract from the Clinical Evaluation Report · This document provides a more detailed evaluation of the clinical findings, extracted from the Clinical Evaluation Report (CER) prepared by the TGA. This extract does not include sections from the CER regarding product documentation or post market activities. · The words [Information redacted], where they appear in this document, indicate that confidential information has been deleted. · For the most recent Product Information (PI), please refer to the TGA website <https://www.tga.gov.au/product-information-pi>. Copyright © Commonwealth of Australia 2018 This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to < [email protected]>. Attachment 2 – AusPAR - Trumenba - Meningococcal group B vaccine - Pfizer Australia Pty Ltd - PM-2016- Page 2 of 72 02079-1-2 - Extract from the Clinical Evaluation Report FINAL 27 August 2018 Therapeutic Goods Administration Contents List of abbreviations __________________________________________________________ 5 1. Introduction _____________________________________________________________ 10 1.1. Submission type ___________________________________________________________ 10 1.2. Drug class and therapeutic indication ___________________________________ 10 1.3. Dosage forms and strengths ______________________________________________ 10 1.4. Dosage and administration _______________________________________________ 10 1.5. Information on the condition being treated _____________________________ 10 1.6. Current treatment options and clinical rationale _______________________ 10 2. Clinical rationale _______________________________________________________ 11 3. Contents of the clinical dossier ______________________________________ 11 3.1. Scope of the clinical dossier _______________________________________________ 11 3.2. Paediatric data _____________________________________________________________ 11 3.3. Good clinical practice ______________________________________________________ 11 4. Pharmacokinetics ______________________________________________________ 12 5. Pharmacodynamics ____________________________________________________ 12 6. Dosage selection for the pivotal studies ___________________________ 12 6.1. Evaluator’s conclusions on dose finding for the pivotal studies _______ 13 7. Clinical efficacy _________________________________________________________ 13 7.1. Pivotal or main efficacy studies___________________________________________ 14 7.2. Other efficacy studies _____________________________________________________ 37 7.3. Analyses performed across trials: pooled and meta-analyses _________ 47 7.4. Evaluator’s conclusions on clinical efficacy ______________________________ 48 8. Clinical safety ___________________________________________________________ 50 8.1. Studies providing evaluable safety data _________________________________ 50 8.2. Studies that assessed safety as the sole primary outcome _____________ 50 8.3. Patient exposure ___________________________________________________________ 51 8.4. Adverse events _____________________________________________________________ 52 8.5. Evaluation of issues with possible regulatory impact __________________ 66 8.6. Other safety issues _________________________________________________________ 67 8.7. Post marketing experience________________________________________________ 67 8.8. Evaluator’s overall conclusions on clinical safety _______________________ 68 9. First round benefit-risk assessment ________________________________ 69 9.1. First round assessment of benefits _______________________________________ 69 9.2. First round assessment of risks __________________________________________ 70 Attachment 2 – AusPAR - Trumenba - Meningococcal group B vaccine - Pfizer Australia Pty Ltd - PM-2016- Page 3 of 72 02079-1-2 - Extract from the Clinical Evaluation Report FINAL 27 August 2018 Therapeutic Goods Administration 9.3. First round assessment of benefit-risk balance _________________________ 71 10. First round recommendation regarding authorisation _______ 71 11. Clinical questions ____________________________________________________ 71 12. References ____________________________________________________________ 71 Attachment 2 – AusPAR - Trumenba - Meningococcal group B vaccine - Pfizer Australia Pty Ltd - PM-2016- Page 4 of 72 02079-1-2 - Extract from the Clinical Evaluation Report FINAL 27 August 2018 Therapeutic Goods Administration List of abbreviations Abbreviation Meaning 1/dil 4 reciprocal of dilution Ab antibody CMenB Multicomponent meningococcal serogroup B vaccine ABC Active Bacterial Core ACIP Advisory Committee on Immunization Practices Adacel tetanus, low-dose diphtheria, and low-dose acellular pertussis vaccine (Tdap) AE adverse event AlPO4 aluminum phosphate ANSM Agence Nationale de Sécurité du Medicament Anti-TPO anti-thyroid peroxidase ASO antistreptolysin O Aus Australia BLA Biologic License Application CBER Center for Biologics Evaluation and Research CC clonal complex type CDC Centers for Disease Control and Prevention CFR Code of Federal Regulation CHMP Committee for Medicinal Products for Human Use CI confidence interval cLIA competitive Luminex immunoassay CRM197 cross-reactive material-197 CSR clinical study report dTAP low-dose diphtheria, tetanus, and low-dose acellular pertussis vaccine Attachment 2 – AusPAR - Trumenba - Meningococcal group B vaccine - Pfizer Australia Pty Ltd - PM-2016- Page 5 of 72 02079-1-2 - Extract from the Clinical Evaluation Report FINAL 27 August 2018 Therapeutic Goods Administration Abbreviation Meaning e-diary electronic diary EEA European Economic Area EU European Union FDA Food and Drug Administration factor H binding protein (referring to the bacterial lipoprotein expressed on surface of N meningitidis) Gardasil human papilloma virus vaccine (HPV) GCP Good Clinical Practice GMR geometric mean ratio GMT geometric mean titre HAV hepatitis A virus vaccine Havrix hepatitis A virus vaccine (HAV) HPV human papilloma virus vaccine hSBA serum bactericidal assay using human complement ICD informed consent document ICH International Conference on Harmonisation IgA Immunoglobulin A IgG Immunoglobulin G IMD invasive meningococcal disease IPV inactivated poliomyelitis virus vaccine ISE integrated summary of efficacy ISS integrated summary of safety iTT intent-to-treat LAL Limulus amoebocyte lysate assay LCI lower bound confidence interval LLOQ lower limit of quantitation Attachment 2 – AusPAR - Trumenba - Meningococcal group B vaccine - Pfizer Australia Pty Ltd - PM-2016- Page 6 of 72 02079-1-2 - Extract from the Clinical Evaluation Report FINAL 27 August 2018 Therapeutic Goods Administration Abbreviation Meaning LOD limit of detection LOS lipooligosaccharide LP2086 lipoprotein (referring to the recombinant fHBP or fHBP vaccine antigen) LXA Luminex assay MAA marketing authorization application MAC membrane attack complex MAE medically attended adverse event MCC meningococcal serogroup C conjugate MCV4 quadrivalent meningococcal polysaccharide conjugate vaccine MedDRA Medical Dictionary for Regulatory Activities Menactra meningococcal (Groups A, C, Y, and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV4) MenACWY- Menveo, tetravalent meningococcal conjugate vaccine CRM197 MenAfriVac meningococcal A conjugate vaccine Menomune tetravalent meningococcal polysaccharide vaccine Menveo tetravalent meningococcal conjugate vaccine, MenACWY-CRM197 MeNZB meningococcal serogroup B outer
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