title: Safety and immunogenicity of a quadrivalent meningococcal conjugate vaccine (MenACYW-DT): a multicenter, open-label, non-randomized, phase III clinical trial.
abstract: OBJECTIVE
  To assess the safety and immunogenicity of a quadrivalent meningococcal (groups A,C,Y,W) polysaccharide diphtheria toxoid conjugate vaccine (MenACYW-DT) in India.
  
  
  METHODS
  Open-label, descriptive, non-randomized study.
  
  
  METHODS
  Three medical college hospitals, one each in New Delhi, Bengaluru and Mumbai, India.
  
  
  METHODS
  300 healthy, vaccine-naïve participants (100 children aged 2-11 years, 100 adolescents aged 12-17 years, and 100 adults aged 18-55 years).
  
  
  METHODS
  One dose (0.5 mL) of MenACYW-DT administered intramuscularly.
  
  
  METHODS
  Serum bactericidal antibody titers against A, C, Y, and W were measured before and after MenACWY-DT vaccination. Safety data were also collected.
  
  
  RESULTS
  Thirty days post-vaccination, geometric mean titers rose across all serogroups. Most participants had protective titers >8 (1/dil) across the four serogroups. The percentage (95% CI) achieving >8 (1/dil) in the Adolescent Group was typical - A: 96.9% (91.2%; 99.4%); C: 96.9% (91.2%; 99.4%); Y:100% (96.3%; 100%); W:100% (96.3%; 100%). In general, solicited reactions were mild and short-lived. Unsolicited events were uncommon and unrelated to vaccination.
  
  
  CONCLUSIONS
  MenACYW-DT was well tolerated and elicited a robust and protective immune response 30 days post-vaccination against meningococcal serogroups A, C, Y, and W-135 in the Indian study participants aged 2-55 years.
authors.affiliation: Departments of Pediatrics, Maulana Azad Medical College and Lok Nayak Hospital, New Delhi, India; #Lokmanya Tilak Municipal Medical College and General Hospital; Mumbai, India; Community Medicine, Kempegowda Institute of Medical Sciences (KIMS), Bangalore, India; Sanofi Pasteur India Pvt Ltd, Mumbai, India; and Sanofi Pasteur, Lyon, France. Correspondence to: Dr Rohit Arora, Sanofi Pasteur India Pvt Ltd, 54/A, Sir Mathuradas Vasanji Road, Andheri East, Mumbai 400 093, India. DrRohit.Arora@sanofipasteur.com.
authors.forename: Sangeeta
authors.initials: S
authors.lastname: Yadav
authors.forename: M V
authors.initials: MV
authors.lastname: Manglani
authors.forename: Dh Ashwath
authors.initials: DA
authors.lastname: Narayan
authors.forename: S
authors.initials: S
authors.lastname: Sharma
authors.forename: H S
authors.initials: HS
authors.lastname: Ravish
authors.forename: R
authors.initials: R
authors.lastname: Arora
authors.forename: V Bosch
authors.initials: VB
authors.lastname: Castells
authors.forename: S
authors.initials: S
authors.lastname: Arya
authors.forename: P
authors.initials: P
authors.lastname: Oster
mesh_terms: D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood*; D002648:Child; D002675:Child, Preschool; D006801:Humans; D007194:India / Q000453:epidemiology; D008589:Meningococcal Infections / Q000517:prevention & control; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D008875:Middle Aged; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: D000907:Antibodies, Bacterial; C525703:MenACWY; D022401:Meningococcal Vaccines; D018074:Vaccines, Conjugate