DOCSLIB.ORG

Immunogenicity and Safety of an Investigational Quadrivalent

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Immunogenicity and Safety of an Investigational Quadrivalent Sanofi Pasteur MET57MET57 395 – MenACYW Conjugate Vaccine Protocol Version 4.0 NCT Number: NCT03205371 Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly with Other Pediatric Vaccines in Healthy Toddlers Phase III, open-label (immunology laboratory technicians will be blinded to group assignment), randomized, parallel-group, active-controlled, multi-center study to describe the immunogenicity and safety of a single dose of MenACYW conjugate vaccine when administered alone and when administered concomitantly with other pediatric vaccines in healthy toddlers in South Korea, Thailand, the Russian Federation, and Mexico Clinical Trial Protocol, Amendment 3 Health Authority File Numbers: Korea, Republic of (or South Korea): 20160036536 The Russian Federation: Not available The United Mexican States (Mexico): 163300410A0093 Thailand Not available WHO Universal Trial Number U1111-1161-2787 (UTN): Trial Code: MET57 Development Phase: Phase III Sponsor: Sanofi Pasteur Inc. Discovery Drive, Swiftwater, PA 18370-0187, USA Investigational Product: MenACYW conjugate vaccine: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine Form / Route: Liquid Solution / Intramuscular Indication For This Study: MenACYW conjugate vaccine as a single dose in toddlers 12 to 23 months old Manufacturer: Same as Sponsor Coordinating Investigators: Korea: The Russian Federation: Mexico: Confidential/Proprietary Information Page Page 1 1 of of 105 106 Sanofi Pasteur MET57MET57 395 – MenACYW Conjugate Vaccine Protocol Version 4.0 Principal Investigators: Thailand: Sponsor’s Responsible Medical Officer: , Sanofi Pasteur Inc. Tel: Fax: Regional Directors of Clinical Development: Sanofi Pasteur Inc. Address: Fax: , Sanofi Pasteur Inc. Address: Tel: Fax: , Sanofi Pasteur Ltd. Address: Tel: Fax: Product Safety Officer: , Sanofi Pasteur Inc. Tel: Fax: Regional Clinical Trial Managers: , Sanofi Pasteur, SA Address: Tel: Sanofi Pasteur Inc. Address: Tel: , Sanofi Pasteur, México Address: Tel: , Sanofi Pasteur, Ltd. Address: Tel: Confidential/Proprietary Information Page Page 2 2 of of 105 106 Sanofi Pasteur MET57MET57 395 – MenACYW Conjugate Vaccine Protocol Version 4.0 Version and Date of the Protocol: Version 4.0 dated 11 September 2017 This protocol version 4.0 is the third amendment to the initial trial protocol version 1.0, dated 15 January 2016. It is preceded by Amendment 1 (protocol version 2.0, dated 11 July 2016) and Amendment 2 (protocol version 3.0, dated 05 May 2017). Information contained in this publication is the property of Sanofi Pasteur and is confidential. This information may not be disclosed to third parties without written authorization from Sanofi Pasteur. This document may not be reproduced, stored in a retrieval system, or transmitted in any form or by any means–electronic, mechanical recording, or otherwise–without prior authorization from Sanofi Pasteur. This document must be returned to Sanofi Pasteur upon request. Confidential/Proprietary Information Page Page 3 3 of of 105 106 Sanofi Pasteur MET57MET57 395 – MenACYW Conjugate Vaccine Protocol Version 4.0 Table of Contents List of Tables .................................................................................................................................... 9 Synopsis .......................................................................................................................................... 10 Table of Study Procedures - Subjects in South Korea, Mexico, and Thailand ....................... 25 Table of Study Procedures - Subjects in the Russian Federation Only.................................... 26 List of Abbreviations ..................................................................................................................... 28 1 Introduction ..................................................................................................................... 31 1.1 Background ..................................................................................................................... 31 1.2 Background of the Investigational Product ..................................................................... 32 1.2.1 Non-clinical Safety ....................................................................................................... 32 1.2.2 Clinical ......................................................................................................................... 32 1.2.2.1 Study MET32 (Phase I/II) .......................................................................................... 33 1.2.2.2 Study MET39 (Phase II) ............................................................................................ 33 1.2.2.3 Study MET44 (Phase II) ............................................................................................ 34 1.2.2.4 Study MET54 (Phase II) ............................................................................................ 35 1.3 Potential Benefits and Risks ........................................................................................... 36 1.3.1 Potential Benefits to Subjects ....................................................................................... 36 1.3.2 Potential Risks to Subjects ........................................................................................... 37 1.4 Rationale for the Trial ..................................................................................................... 38 2 Trial Objectives ............................................................................................................... 38 2.1 Primary Objective ........................................................................................................... 38 2.2 Secondary Objective ....................................................................................................... 38 2.3 Observational Objectives ................................................................................................ 39 3 Investigators and Trial Organization ............................................................................ 39 4 Independent Ethics Committee / Institutional Review Board .................................... 39 5 Investigational Plan ......................................................................................................... 40 5.1 Description of the Overall Trial Design and Plan ........................................................... 40 5.1.1 Trial Design .................................................................................................................. 40 5.1.2 Justification of the Trial Design ................................................................................... 42 5.1.3 Trial Plan ...................................................................................................................... 43 5.1.4 Visit Procedures ............................................................................................................ 46 Confidential/Proprietary Information Page Page 4 4 of of 105 106 Sanofi Pasteur MET57MET57 395 – MenACYW Conjugate Vaccine Protocol Version 4.0 5.1.5 Planned Trial Calendar ................................................................................................. 50 5.1.6 Early Safety Data Review............................................................................................. 50 5.2 Enrollment and Retention of Trial Population ................................................................ 50 5.2.1 Recruitment Procedures ................................................................................................ 50 5.2.2 Informed Consent Procedures ...................................................................................... 50 5.2.3 Screening Criteria ......................................................................................................... 51 5.2.4 Inclusion Criteria .......................................................................................................... 52 5.2.5 Exclusion Criteria ......................................................................................................... 53 5.2.6 Medical History ............................................................................................................ 54 5.2.7 Contraindications for Subsequent Vaccinations ........................................................... 55 5.2.8 Temporary Contraindications for Visit 2 Blood Draw ................................................. 55 5.2.9 Conditions for Withdrawal ........................................................................................... 55 5.2.10 Lost to Follow-up Procedures....................................................................................... 56 5.2.11 Classification of Subjects Who Discontinue the Trial.................................................. 56 5.2.12 Follow-up of Discontinuations ..................................................................................... 57 5.3 Safety Emergency Call ................................................................................................... 57 5.4 Modification of the Trial and Protocol ........................................................................... 57 5.5 Interruption of the Trial .................................................................................................. 57 6 Vaccines Administered ..................................................................................................
Load more

Recommended publications
  • The Hexavalent Dtap/IPV/Hib/Hepb Combination Vaccine: Information for Healthcare Practitioners About the Neonatal Selective
    The hexavalent DTaP/IPV/Hib/HepB combination vaccine Information for healthcare practitioners about the neonatal selective immunisation programme for babies at risk of hepatitis B The Hexavalent DTaP/IPV/Hib/HepB combination vaccine: Information for Healthcare Practitioners (selective programme) About Public Health England Public Health England exists to protect and improve the nation’s health and wellbeing, and reduce health inequalities. We do this through world-leading science, research, knowledge and intelligence, advocacy, partnerships and the delivery of specialist public health services. We are an executive agency of the Department of Health and Social Care, and a distinct delivery organisation with operational autonomy. We provide government, local government, the NHS, Parliament, industry and the public with evidence-based professional, scientific and delivery expertise and support. Public Health England Wellington House 133-155 Waterloo Road London SE1 8UG Tel: 020 7654 8000 www.gov.uk/phe Twitter: @PHE_uk Facebook: www.facebook.com/PublicHealthEngland For queries relating to this document, please contact: [email protected] © Crown copyright 2020 You may re-use this information (excluding logos) free of charge in any format or medium, under the terms of the Open Government Licence v3.0. To view this licence, visit OGL. Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. First published November 2017 This updated version published February
    [Show full text]
  • Download File (Pdf)
    2021 FORUM REPORT COVID-19 in Africa one year on: Impact and Prospects MO IBRAHIM FOUNDATION 2021 FORUM REPORT COVID-19 in Africa one year on: Impact and Prospects MO IBRAHIM FOUNDATION Foreword by Mo Ibrahim Notwithstanding these measures, on current projections Founder and Chair of the Mo Ibrahim Africa might not be adequately covered before 2023. Foundation (MIF) Vaccinating Africa is an urgent matter of global security and all the generous commitments made by Africa’s partners must now be delivered. Looking ahead - and inevitably there will be future pandemics - Africa needs to significantly enhance its Over a year ago, the emergence and the spread of COVID-19 homegrown vaccine manufacturing capacity. shook the world and changed life as we knew it. Planes were Africa’s progress towards its development agendas was off grounded, borders were closed, cities were shut down and course even before COVID-19 hit and recent events have people were told to stay at home. Other regions were hit created new setbacks for human development. With very earlier and harder, but Africa has not been spared from the limited access to remote learning, Africa’s youth missed out pandemic and its impact. on seven months of schooling. Women and girls especially The 2021 Ibrahim Forum Report provides a comprehensive are facing increased vulnerabilities, including rising gender- analysis of this impact from the perspectives of health, based violence. society, politics, and economics. Informed by the latest data, The strong economic and social impacts of the pandemic it sets out the challenges exposed by the pandemic and the are likely to create new triggers for instability and insecurity.
    [Show full text]
  • UNICEF Pentavalent-Hexa 2021+ Pre-Tender Industry Consultation
    UNICEF Pentavalent-Hexa 2021+ Pre-Tender Industry Consultation 19th SEPTEMBER 2019 1 Presentation Outline 1. Context ▪ Gavi Board decision ▪ Hexa strategic alignment ▪ Value Based Assessment 2. Demand scenarios and assumptions 3. Pentavalent Tender: ▪ Objectives ▪ Scope ▪ Duration ▪ Modality 4. Summary of feedback and response to questionnaire 5. Timelines 1. CONTEXT Gavi Board decision Hexa strategic alignment Value Based Assessment 3 Gavi Board November 2018 – Decisions IPV Post-2020 DTP booster VIS 2018 VIS 2018 + Hexavalent as immunisation option • Approved support for D, T & P vaccines (Td, DTwP, pentavalent) to be used as booster doses beginning in 2021 • Approved support for inactivated poliovirus vaccine (IPV), with country financing arrangements subject to alignment with the final parameter setting for Gavi 5.0 at the June 2019 Board meeting* • Approved in principle support of wP-Hexavalent vaccine, subject to a vaccine being licenced, recommended for use by WHO, WHO pre-qualified and that market attributes support the successful implementation of Hexavalent The development of capacity for standalone IPV remains the main priority for Gavi Alliance as part of the effort to eradicate polio All Gavi Board decisions are “subject to the availability of funding for the 2021-2025 period and alignment with the final parameter setting for Gavi 5.0 at the June 2019 Board meeting.” *Gavi's Board approved IPV co-financing arrangements post-2020 in its June 2019 session 4 Conditions to open a funding window for Hexavalent Condition 1: Hexavalent vaccines that are candidates for Gavi support should achieve IPV immunogenicity targets as per WHO’s SAGE recommendations. Condition 2: Hexavalent vaccines are priced in line with value-based principles.
    [Show full text]
  • Case Studies Controversies in Vaccination
    European Review, Vol. 21, No. S1, S56–S61 r 2013 Academia Europæa. The online version of this article is published within an Open Access environment subject to the conditions of the Creative Commons Attribution license ,http://creativecommons.org/licenses/by/3.0/.. doi:10.1017/S1062798713000227 Session 3 – Case Studies Controversies in Vaccination ROMAN PRYMULA University Hospital Hradec Kralove, Sokolska 581, 500 05 Hradec Kralove, Czech Republic. E-mail: [email protected] Infectious diseases still jeopardize human health and even lives. In spite of the variety of advanced treatment methods, prevention is considered to be the most effective way to fight infections, and vaccination, no doubt, is one of the most effective preventive measures in the history of mankind. The vaccine controversy is based on a dispute over morality, ethics, effectiveness, and/or safety. There is no 100% safe or effective vaccine; however, benefits clearly overweigh risks. Ironically, as the numbers of cases of vaccine- preventable infectious diseases are falling, the controversies relating to vaccine safety are growing. Vaccines are generally victims of their own success. Controversies can afflict the positive acceptance of immunization, decrease the coverage and uptake and finally threaten the health of children and adults. The advent of vaccination has proven to be one of the most effective preventive measures in the history of medicine. Vaccines play a significant role in the prevention of debili- tating and, in many cases, life-threatening infectious diseases. Vaccines also provide important benefits in terms of reducing or avoiding costs associated with illness, both direct and indirect. In spite of the absence of any kind of ideal global healthcare system and lack of resources, the World Health Organisation (WHO) and the United Nations Children’s Fund (UNICEF) were able, in 1974, to establish a major global project called the Expanded Programme on Immunization (EPI).
    [Show full text]
  • Immunogenicity and Safety of a Fully Liquid Dtap-IPV-Hep B-PRP-T
    ccines & a V f V a o c l c i a n n a Lanata et al., J Vaccines Vaccin 2012, 3:1 r t u i o o n J Journal of Vaccines & Vaccination DOI: 10.4172/2157-7560.1000128 ISSN: 2157-7560 Research Article Open Access Immunogenicity and Safety of a Fully Liquid DTaP-IPV-Hep B-PRP-T Vaccine at 2-4-6 Months of Age in Peru Claudio Lanata1, Betzana Zambrano2, Lucie Ecker1, Isabel Amemiya1, Ana Gil1 and Eduardo Santos Lima3* 1Instituto de Investigación Nutricional, Lima, Peru 2Sanofi Pasteur, Montevideo, Uruguay 3Clinical Development, Sanofi Pasteur, Lyon, France Abstract Objectives: To assess the immunogenicity and safety of a new candidate, fully liquid, hexavalent DTaP-IPV- Hep B-PRP-T vaccine (Hexaxim™, an AcXim family vaccine) compared to a licensed hexavalent DTaP-IPV-Hep B// PRP-T vaccine (Infanrix hexa®) in Peru. Methods: Infants born to HBsAg seronegative mothers and who had not received a hepatitis B vaccine prior to entry into the study were randomized to receive either Hexaxim™ (Group 1) or Infanrix hexa® (Group 2) at 2, 4, 6 months of age. Seroprotection (SP) rate for hepatitis B (anti-HBs antibody concentration ≥10 mIU/mL) was analysed for non-inferiority (Group 1 minus Group 2) 1 month post-primary series. Anti-diphtheria and anti-polyrosil ribitol phosphate (PRP) antibody responses were analysed descriptively. Safety was analysed from parental reports. Results: Seroprotection rate for anti-HBs antibody titers ≥10 mIU/mL was high in both groups (≥99.2%) and non-inferiority was demonstrated (lower bound of the 95% CI for the difference was -4.17, above the pre-defined delta [-10%]).
    [Show full text]
  • (Nitags) and WHO Immunisation-Related Advisory Committees
    Summary of recent issues considered by four national immunisation technical advisory groups (NITAGs) and WHO immunisation-related advisory committees Prepared by the National Centre for Immunisation Research & Surveillance (NCIRS) Period of review: 16/05/2019 to 13/09/2019 Contents 1 Advisory Committee on Immunization Practices (ACIP), USA .......................................................... 3 1.1 ACIP meeting: 26-27 June 2019 ....................................................................................................... 3 1.2 Newly published or updated recommendations ............................................................................... 20 1.2.1 Japanese Encephalitis Vaccine: Recommendations of the Advisory Committee on Immunisation Practices.......................................................................................................................... 20 1.2.2 Human Papillomavirus Vaccination for Adults: Updated Recommendations of the Advisory Committee on Immunization Practice ..................................................................................................... 20 1.2.3 Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2019–20 Influenza Season ............ 21 1.3 New or updated recommendations – not yet published ................................................................... 21 2 Immunisation Advisory Centre (IMAC), New Zealand ....................................................................
    [Show full text]
  • Gavi's Role in Market Shaping and Procurement
    CGD NOTE Jun 2019 Gavi’s Role in Market Shaping and Procurement: Progress, Challenges, and Recommendations for an Evolving Approach Janeen Madan Keller, Amanda Glassman INTRODUCTION Market shaping and procurement constitute a core approach to achieve Gavi’s mission to accelerate access to and increase equitable coverage of vaccines.1 Gavi drives lower prices and ensures the supply of high-quality vaccines through a range of tools such as pooling demand with assured funding, of- fering multi-year contracts, and encouraging new suppliers to enter the market, among others.2 Gavi has made notable progress, including securing a sustainable and affordable supply of pentavalent, pneumococcal conjugate (PCV), and rotavirus vaccines;3 expanding and diversifying the manufac- turer base;4 and developing demand forecasts to give manufacturers longer-term market visibility.5 These efforts have no doubt provided benefits to Gavi-supported countries, and they have also had some positive spillovers in Gavi-ineligible countries. Yet several challenges—stemming in part from countries transitioning from Gavi support and an evolving vaccine manufacturer landscape—may impede Gavi’s ability to effectively deliver on its mis- sion in the future. The next five-year strategy (Gavi 5.0) is an opportunity to evolve—and possibly broaden—Gavi’s role in market shaping and procurement. Looking ahead, Gavi will need to more carefully assess the implications of its market shaping strategies beyond Gavi-supported countries— and consider ways to potentially extend its benefits to the entire universe of low- and middle-income 1 See the accompanying note in this series, “Gavi’s Approach to Health Systems Strengthening (HSS): Reforms for Enhanced Effectiveness and Relevance in the 2021-2025 Strategy,” which focuses on delivery platforms to ensure those vaccines reach their target populations—another key pillar of Gavi’s vaccine support.
    [Show full text]
  • Evolving Pharmacovigilance Requirements with Novel Vaccines and Vaccine Components
    Analysis BMJ Glob Health: first published as 10.1136/bmjgh-2020-003403 on 19 May 2021. Downloaded from Evolving pharmacovigilance requirements with novel vaccines and vaccine components 1 2 3 4 Patrick L F Zuber , Marion Gruber, David C Kaslow, Robert T Chen, Brigitte K Giersing,5 Martin H Friede5 To cite: Zuber PLF, Gruber M, ABSTRACT Summary box Kaslow DC, et al. Evolving This paper explores the pipeline of new and upcoming pharmacovigilance requirements vaccines as it relates to monitoring their safety. Compared ► Novel vaccine technologies include genetic mod- with novel vaccines and vaccine with most currently available vaccines, that are constituted components. BMJ Global Health ifications of micro- organisms, viral vectors, use of live attenuated organisms or inactive products, future 2021;6:e003403. doi:10.1136/ of nucleic acids or novel adjuvants, they also in- vaccines will also be based on new technologies. Several bmjgh-2020-003403 clude increased valences and different routes of products that include such technologies are either administration. already licensed or at an advanced stage of clinical Handling editor Seye Abimbola ► Those new characteristics will modify untoward development. Those include viral vectors, genetically reactions, specific and non- specific, and will also attenuated live organisms, nucleic acid vaccines, novel Received 9 July 2020 require new pharmaco-epidemiological approaches. Revised 4 August 2020 adjuvants, increased number of antigens present in a ► The risk management plans for those products will Accepted 9 August 2020 single vaccine, novel mode of vaccine administration and have to factor those new theoretical concerns and thermostabilisation. The Global Advisory Committee on propose ways of monitoring them during the prod- Vaccine Safety (GACVS) monitors novel vaccines, from the ucts life- cycle.
    [Show full text]
  • Clinical Reviewer: Ann T Schwartz STN: 125563/0
    Individuals using assistive technology may not be able to fully access the information contained in this file. For assistance, please send an e-mail to: [email protected] and include 508 Accommodation and the title of the document in the subject line of your e-mail. Clinical Reviewer: Ann T Schwartz STN: 125563/0 Application Type Original Application STN 125563/0 CBER Received Date August 12, 2014 PDUFA Goal Date August 12, 2015 Complete Response Letter November 01, 2015 Resubmission Action Due Date December 29, 2018 Division / Office DVRPA /OVRR Priority Review No Reviewer Name(s) Ann Schwartz, M.D. Review Completion Date / Stamped Date Supervisory Concurrence R. Douglas Pratt, MD MPH Associate Director for Medical Affairs Concurrence Date / Stamped Date Applicant MCM Vaccine Co. [partnership between Merck Sharp & Dohme Corp. (a subsidiary of Merck and Co., Inc.) and Sanofi Pasteur Inc.] Established Name Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine (Proposed) Trade Name VAXELIS Pharmacologic Class Vaccine Formulation(s), including Adjuvants Suspension for injection, each 0.5 mL dose contains: PT 20 μg FHA 20 μg FIM 5 μg PRN 3 μg Diphtheria 15 Lf Tetanus 5 Lf Vero-derived IPV-Type 1: 29 D-antigen Units Vero-derived IPV-Type 2: 7 D-antigen Units Vero-derived IPV-Type 3: 26 D-antigen Units HBsAg 10 μg PRP-OMPC 3 μg Aluminum (b) (4) μg Dosing Regimen Single intramuscular dose at 2,4 and 6 months of age Indication(s) and Intended Active immunization against diphtheria, tetanus, Population(s) pertussis, poliomyelitis (caused by poliovirus Types 1, 2, and 3), against invasive disease caused by Haemophilus influenzae type b and infection caused by all known subtypes of hepatitis B virus in children 6 weeks through 4 years of age.
    [Show full text]
  • Vaccine Update: Issue 258, February 2017
    1 Vaccine update: Issue 258, February 2017 VACCINE UPDATE Issue 296, July 2019 SPECIAL EDITION SPECIAL EDITION SPECIAL EDITION SPECIAL EDITION SPECIAL EDITION SPECIAL EDITION SP vaccine could prevent over 100,000 cancers Estimates suggest that the HPV vaccine programme will lead CONTENTS to the prevention of over 64,000 cervical cancers and nearly Head of Immunisation at PHE 50,000 non-cervical cancers by 2058. Dr Mary Ramsay said From September this year, boys in school year 8 will be offered New vaccine coverage data the free Human Papilloma Virus (HPV) vaccine for the first time. collection tool Attitudinal Surveys and leaflet Worldwide, about 5% of all cancers are linked to testing the HPV virus. This includes cervical, penile, New Arm against Cancer anal and genital cancers and some cancers of resources the head and neck – all of which the vaccine Resources for social media helps to protect against. Cervical cancer is Immunisation schedules 2019 currently the most common cancer in women The Green Book chapter on under 35, killing around 850 women each year. human papilloma virus (HPV) HPV is thought to be responsible for over 99% of has been published! cervical cancers, as well as 90% of anal, about 70% of Training slide set and guidance vaginal and vulvar cancers and more than 60% of penile cancers. Human papillomavirus (HPV) vaccine: PGD template Modelling produced by the University of Warwick estimates that Human papillomavirus (HPV) by 2058 in the UK the HPV vaccine currently being used may vaccine Gardasil have prevented up to 64,138 HPV-related cervical cancers and 49,649 other HPV-related cancers.
    [Show full text]
  • Accepted Article
    [Review article] Recommendation for use of diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b conjugate, and hepatitis B vaccine in infants Running title: Recommendation of hexavalent vaccine in Korea Hye-Kyung Cho, MD, PhD1, Su Eun Park, MD, PhD2, Yae-Jean Kim, MD, PhD3, Dae Sun Jo, MD, PhD4, Yun-Kyung Kim, MD, PhD5, Byung-Wook Eun, MD, PhD6, Taek-Jin Lee, MD, PhD7, Jina Lee, MD, PhD8, Hyunju Lee, MD, PhD9, Ki Hwan Kim, MD, PhD10,*, Eun Young Cho, MD, PhD11, Jong Gyun Ahn, MD, PhD12, Eun Hwa Choi, MD, PhD9; The Committee on Infectious Diseases of the Korean Pediatric Society 1Department of Pediatrics, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea; 2Department of Pediatrics, School of Medicine, Pusan National University, Pusan, Korea; 3Department of Pediatrics, Sungkyunkwan University School of Medicine, Suwon, Korea; 4DepartmentAccepted of Pediatrics, Jeonbuk NationalArticle University Medical School, Jeonju, Korea; 5Department of Pediatrics, Korea University College of Medicine, Seoul, Korea; 6Department of Pediatrics, School of Medicine, Eulji University, Daejeon, Korea; 7Department of Pediatrics, CHA University School of Medicine, Pocheon, Korea; 8Department of Pediatrics, University of Ulsan College of Medicine, Ulsan, Korea; 9Department of Pediatrics, Seoul National University College of Medicine, Seoul, Korea; 10Department of Pediatrics, College of Medicine, The Catholic University of Korea, Seoul, 1 Korea; 11Department of Pediatrics, Chungnam National University School of Medicine, Daejeon, Korea; 12Department of Pediatrics, Severance Children’s Hospital, Yonsei University College of Medicine, Seoul, Korea Corresponding author Eun Hwa Choi, MD, PhD Department of Pediatrics, Seoul National University College of Medicine, Seoul, Korea.
    [Show full text]
  • Licensure of a Diphtheria and Tetanus Toxoids and Acellular Pertussis
    Morbidity and Mortality Weekly Report Licensure of a Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus influenzae Type b Conjugate, and Hepatitis B Vaccine, and Guidance for Use in Infants Sara E. Oliver MD1; Kelly L. Moore, MD2 On December 21, 2018 the Food and Drug Administration new hexavalent combination vaccine (DTaP-IPV-Hib-HepB) (FDA) licensed a hexavalent combined diphtheria and tetanus from the MCM Vaccine Company, a joint venture between toxoids and acellular pertussis (DTaP) adsorbed, inactivated Merck and Sanofi Pasteur, received FDA approval. Each dose poliovirus (IPV), Haemophilus influenzae type b (Hib) conju- of DTaP-IPV-Hib-HepB contains the same amount of diph- gate (meningococcal protein conjugate) and hepatitis B (HepB) theria and tetanus toxoids and pertussis antigens (inactivated (recombinant) vaccine, DTaP-IPV-Hib-HepB (Vaxelis; MCM pertussis toxin [PT], filamentous hemagglutinin [FHA], Vaccine Company),* for use as a 3-dose series in infants at ages pertactin, and fimbriae types 2 and 3) as does Pentacel. The 2, 4, and 6 months (1). On June 26, 2019, after reviewing poliovirus component of DTaP-IPV-Hib-HepB contains the data on safety and immunogenicity, the Advisory Committee same strains of inactivated poliovirus types 1, 2, and 3 as the on Immunization Practices (ACIP)† voted to include DTaP- poliovirus vaccine IPOL (Sanofi Pasteur), but in decreased IPV-Hib-HepB in the federal Vaccines for Children (VFC) amounts. The HIB component (Hib capsular polysaccharide program.§ This report summarizes the indications for DTaP- polyribosyl-ribotol-phosphate [PRP] coupled to the outer IPV-Hib-HepB and provides guidance for its use.
    [Show full text]