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Tytuł:
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Safety and immunogenicity of an investigational meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy Indian subjects aged 2 to 75 years.
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Autorzy:
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Lalwani S; Bharati Vidyapeeth University Medical College and Hospital, Pune, India.
Agarkhedkar S; Padmasree Dr. D. Y. Patil Medical College, Hospital and Research Center, Pune, India.
Gogtay N; Seth GS Medical College and KEM Hospital, Mumbai, India.
Palkar S; Bharati Vidyapeeth University Medical College and Hospital, Pune, India.
Agarkhedkar S; Padmasree Dr. D. Y. Patil Medical College, Hospital and Research Center, Pune, India.
Thatte U; Seth GS Medical College and KEM Hospital, Mumbai, India.
Vakil H; Novartis Healthcare Pvt. Ltd, Hyderabad, India.
Jonnalagedda R; Novartis Healthcare Pvt. Ltd, Hyderabad, India.
Pedotti P; GlaxoSmithKline B.V., Amsterdam, The Netherlands.
Hoyle M; Novartis Vaccines and Diagnostics S.r.l. (a GSK company), Via Fiorentina, 1, I-53100 Siena, Italy.
Bhusal C; Novartis Vaccines and Diagnostics S.r.l. (a GSK company), Via Fiorentina, 1, I-53100 Siena, Italy.
Arora A; Novartis Vaccines and Diagnostics S.r.l. (a GSK company), Via Fiorentina, 1, I-53100 Siena, Italy. Electronic address: .
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Źródło:
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International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases [Int J Infect Dis] 2015 Sep; Vol. 38, pp. 36-42. Date of Electronic Publication: 2015 Jul 09.
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Typ publikacji:
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Clinical Trial, Phase III; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
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Język:
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English
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Imprint Name(s):
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Publication: Hamilton, ON : Elsevier
Original Publication: Hamilton, ON : Decker, c1996-
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MeSH Terms:
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Meningococcal Infections/*prevention & control
Meningococcal Vaccines/*adverse effects
Meningococcal Vaccines/*immunology
Adolescent ; Adult ; Aged ; Antibodies, Bacterial/blood ; Child ; Child, Preschool ; Female ; Humans ; India ; Male ; Middle Aged ; Neisseria meningitidis/classification ; Neisseria meningitidis/immunology ; Serogroup ; Vaccines, Conjugate/adverse effects ; Vaccines, Conjugate/immunology ; Young Adult
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Contributed Indexing:
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Keywords: CRM(197) conjugate; Immunogenicity; India; Meningococcal disease; Quadrivalent vaccine; Safety
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Substance Nomenclature:
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0 (Antibodies, Bacterial)
0 (MenACWY)
0 (Meningococcal Vaccines)
0 (Vaccines, Conjugate)
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Entry Date(s):
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Date Created: 20150714 Date Completed: 20160630 Latest Revision: 20220409
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Update Code:
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20240104
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DOI:
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10.1016/j.ijid.2015.07.003
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PMID:
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26166699
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Background: This phase 3, multi-center, open-label study evaluated the immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM, Menveo(®); Novartis Vaccines and Diagnostics S.r.l., Siena, Italy) in healthy Indian subjects aged 2-75 years, to provide data for licensure in India.
Methods: A total of 180 subjects were enrolled (60 subjects 2-10 years, 60 subjects 11-18 years, and 60 subjects 19-75 years) and received one dose of MenACWY-CRM. Serum bactericidal activity with human complement (hSBA) was measured before and 1 month after vaccination. Adverse events were collected throughout the 29-day study period.
Results: Percentages of subjects with post-vaccination hSBA ≥8 were 72%, 95%, 94%, and 90% for serogroups A, C, W, and Y, respectively. Geometric mean titers rose 7-fold to 42-fold against the four serogroups. Similar immune responses were observed for the age subgroups 2-10 years, 11-18 years, and 19-75 years. Seroresponse rates at 1 month following vaccination were 72%, 88%, 55%, and 71% for serogroups A, C, W, and Y, respectively. The vaccine was well tolerated with no safety concerns.
Conclusion: A single dose of MenACWY-CRM induced a robust immune response against all four meningococcal serogroups and was well tolerated in an Indian population 2-75 years of age.
(Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.)
