title: Immunogenicity and safety of early vaccination with two doses of a combined measles-mumps-rubella-varicella vaccine in healthy Indian children from 9 months of age: a phase III, randomised, non-inferiority trial.
abstract: OBJECTIVE
  This study (NCT00969436) compared the immunogenicity and safety of measles-mumps-rubella (MMR) followed by MMR+varicella (V) vaccines to (1) 2 doses of combined MMRV and (2) MMR followed by MMRV, in Indian children.
  
  
  METHODS
  Phase III, open, randomised, non-inferiority study.
  
  
  METHODS
  6 tertiary care hospitals located in India.
  
  
  METHODS
  Healthy participants aged 9-10 months not previously vaccinated against/exposed to measles, mumps, rubella and varicella or without a history of these diseases.
  
  
  METHODS
  Participants were randomised (2:2:1) to receive 2 doses of either MMRV (MMRV/MMRV group) or MMR followed by MMRV (MMR/MMRV group) or MMR followed by MMR+V (MMR/MMR+V, control group) at 9 and 15 months of age. Antibody titres against measles, mumps and rubella were measured using ELISA and against varicella using an immunofluorescence assay.
  
  
  METHODS
  To demonstrate non-inferiority of the 2 vaccination regimens versus the control in terms of seroconversion rates, defined as a group difference with a lower bound of the 95% CI >-10% for each antigen, 43 days postdose 2. Parents/guardians recorded solicited local and general symptoms for a 4-day and 43-day period after each vaccine dose, respectively.
  
  
  RESULTS
  Seroconversion rates postdose 1 ranged from 87.5% to 93.2% for measles, 83.3% to 86.1% for mumps and 98.7% to 100% for rubella across the 3 vaccine groups. The seroconversion rates postdose 2 were 100% for measles, mumps and rubella and at least 95.8% for varicella across the 3 vaccine groups. Non-inferiority of MMRV/MMRV and MMR/MMRV to MMR/MMR+V was achieved for all antigens, 43 days postdose 2. The 3 vaccination regimens were generally well tolerated in terms of solicited local and general symptoms.
  
  
  CONCLUSIONS
  The immune responses elicited by the MMRV/MMRV and MMR/MMRV vaccination regimens were non-inferior to those elicited by the MMR/MMR+V regimen for all antigens. The 3 vaccination schedules also exhibited an acceptable safety profile in Indian children.
  
  
  BACKGROUND
  NCT00969436.
authors.affiliation: Department of Pediatrics, Bharati Vidyapeeth Deemed University, Pune, Maharashtra, India.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Lalwani
authors.affiliation: Department of Pediatrics, Medical College Kolkata, Kolkata, West Bengal, India.
authors.forename: Sukanta
authors.initials: S
authors.lastname: Chatterjee
authors.affiliation: Kanchi Kamakoti Childs Trust Hospital, Chennai, Tamil Nadu, India.
authors.forename: Sundaram
authors.initials: S
authors.lastname: Balasubramanian
authors.affiliation: Department of Pediatrics, KEM Hospital, Pune, Maharashtra, India.
authors.forename: Ashish
authors.initials: A
authors.lastname: Bavdekar
authors.affiliation: GSK Pharmaceuticals Ltd., Mumbai, Maharashtra, India.
authors.forename: Shailesh
authors.initials: S
authors.lastname: Mehta
authors.affiliation: GSK Vaccines, Wavre, Belgium.
authors.forename: Sanjoy
authors.initials: S
authors.lastname: Datta
authors.affiliation: GSK Vaccines, Wavre, Belgium.
authors.forename: Michael
authors.initials: M
authors.lastname: Povey
authors.affiliation: GSK Vaccines, King of Prussia, Philadelphia, USA.
authors.forename: Ouzama
authors.initials: O
authors.lastname: Henry
mesh_terms: D019433:Chickenpox Vaccine / Q000008:administration & dosage*; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D007115:Immunization Schedule; D007194:India / Q000453:epidemiology; D007223:Infant; D008297:Male; D022542:Measles-Mumps-Rubella Vaccine / Q000008:administration & dosage*; D061214:Patient Safety; D062606:Tertiary Care Centers; D016896:Treatment Outcome; D014611:Vaccination / Q000379:methods*; D017778:Vaccines, Combined / Q000008:administration & dosage*
chemical_list: D019433:Chickenpox Vaccine; D022542:Measles-Mumps-Rubella Vaccine; D017778:Vaccines, Combined; C050102:measles, mumps, rubella, varicella vaccine
keywords: India; immunogenicity; measles-mumps-rubella-varicella vaccine; safety; vaccination schedule