title: Immunogenicity and safety of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine (PRV) in Indian infants.
abstract: OBJECTIVE
  To evaluate the immunogenicity and safety of a pentavalent rotavirus vaccine (PRV) in Indian infants.
  
  
  METHODS
  Open-label, single-arm multicentric study.
  
  
  METHODS
  Hospital facilities (out patients):
  
  
  METHODS
  One hundred and ten (110) healthy Indian infants were enrolled between the ages of 6 weeks and 12 weeks.
  
  
  METHODS
  Three doses of oral pentavalent rotavirus vaccine (PRV) were administered with an interval of 4 to 10 weeks (28 to 70 days).
  
  
  METHODS
  Immunogenicity of PRV was based on the proportion of infants exhibiting a > 3-fold rise in serum anti rotavirus IgA antibodies (from pre dose 1 to 14 days post dose 3). Safety was evaluated for 14 days after each dose.
  
  
  RESULTS
  Of the 110 infants enrolled, 83% exhibited at least a 3-fold rise (seroconversion) in serum anti rotavirus IgA antibodies. There were no clinically significant adverse events reported.
  
  
  CONCLUSIONS
  A 3-dose regimen of PRV was found to be immunogenic and well tolerated in healthy Indian infants.
  
  
  BACKGROUND
  ClinicalTrials.gov; NCT00496054:
authors: Department of Paediatrics, Kashyap Nursing Home, Mumbai Pediatrics, Imperial Mahal, Mumbai, Maharashtra India. mrlokeshwar@gmail.com
authors: M R
authors: MR
authors: Lokeshwar
authors: Sheila
authors: S
authors: Bhave
authors: Ashok
authors: A
authors: Gupta
authors: V K
authors: VK
authors: Goyal
authors: Anuj
authors: A
authors: Walia
mesh_terms: D000914:Antibodies, Viral / Q000097:blood*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D007194:India; D007223:Infant; D008297:Male; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D014611:Vaccination / Q000009:adverse effects* / Q000379:methods*
chemical_list: D000914:Antibodies, Viral; D007070:Immunoglobulin A; D022243:Rotavirus Vaccines; C058442:WC3 rotavirus vaccine