title: Safety and immunogenicity of an investigational meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy Indian subjects aged 2 to 75 years.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Bharati Vidyapeeth University Medical College and Hospital, Pune, India.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Lalwani
authors.affiliation: Padmasree Dr. D. Y. Patil Medical College, Hospital and Research Center, Pune, India.
authors.forename: Sharad
authors.initials: S
authors.lastname: Agarkhedkar
authors.affiliation: Seth GS Medical College and KEM Hospital, Mumbai, India.
authors.forename: Nithya
authors.initials: N
authors.lastname: Gogtay
authors.affiliation: Bharati Vidyapeeth University Medical College and Hospital, Pune, India.
authors.forename: Sonali
authors.initials: S
authors.lastname: Palkar
authors.affiliation: Padmasree Dr. D. Y. Patil Medical College, Hospital and Research Center, Pune, India.
authors.forename: Shalaka
authors.initials: S
authors.lastname: Agarkhedkar
authors.affiliation: Seth GS Medical College and KEM Hospital, Mumbai, India.
authors.forename: Urmila
authors.initials: U
authors.lastname: Thatte
authors.affiliation: Novartis Healthcare Pvt. Ltd, Hyderabad, India.
authors.forename: Hoshang
authors.initials: H
authors.lastname: Vakil
authors.affiliation: Novartis Healthcare Pvt. Ltd, Hyderabad, India.
authors.forename: Rekha
authors.initials: R
authors.lastname: Jonnalagedda
authors.affiliation: GlaxoSmithKline B.V., Amsterdam, The Netherlands.
authors.forename: Paola
authors.initials: P
authors.lastname: Pedotti
authors.affiliation: Novartis Vaccines and Diagnostics S.r.l. (a GSK company), Via Fiorentina, 1, I-53100 Siena, Italy.
authors.forename: Margaret
authors.initials: M
authors.lastname: Hoyle
authors.affiliation: Novartis Vaccines and Diagnostics S.r.l. (a GSK company), Via Fiorentina, 1, I-53100 Siena, Italy.
authors.forename: Chiranjiwi
authors.initials: C
authors.lastname: Bhusal
authors.affiliation: Novartis Vaccines and Diagnostics S.r.l. (a GSK company), Via Fiorentina, 1, I-53100 Siena, Italy. Electronic address: ashwani.k.arora@gsk.com.
authors.forename: Ashwani
authors.initials: A
authors.lastname: Arora
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000907:Antibodies, Bacterial / Q000097:blood; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007194:India; D008297:Male; D008589:Meningococcal Infections / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000009:adverse effects* / Q000276:immunology*; D008875:Middle Aged; D009345:Neisseria meningitidis / Q000145:classification / Q000276:immunology; D065288:Serogroup; D018074:Vaccines, Conjugate / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: D000907:Antibodies, Bacterial; C525703:MenACWY; D022401:Meningococcal Vaccines; D018074:Vaccines, Conjugate
keywords: CRM(197) conjugate; Immunogenicity; India; Meningococcal disease; Quadrivalent vaccine; Safety