Clinical Trial: Coadministration of Measles-rubella and Rotavirus Vaccines

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Non-interference and Safety of Concomitant Administration of Measles-rubella and Rotavirus Vaccines at 9 Months of Age in Rural Bangladesh

Brief Summary: The investigators aim to establish the non-inferiority of concomitant administration of measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of measles seroconversion rates. The primary study hypothesis is the measles seroconversion rate as defined by the percentage of children seroconverting to measles with a measles serum antibody concentration of >=1:120 at 8 weeks post vaccination after the concomitant administration of measles-rubella and rotavirus vaccines is non-inferior to that obtained when measles-rubella vaccine is given alone in children 9 months of age who have received a primary rotavirus vaccine series with the first dose between 6 and 10 weeks and the second at least 4 weeks later and are seronegative for measles antibody in the pre-vaccination sample.

Detailed Summary:
Sponsor: PATH

Current Primary Outcome: measles serum antibody concentration [ Time Frame: 8 weeks post vaccination ]

seroconversion defined as measles serum antibody concentration >=1:120 8 weeks post vaccination in a child seronegative pre-vaccination


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • safety [ Time Frame: Day 0 to Day 56 post vaccination ]
    Immediate reactogenicity, solicited adverse events (diarrhea, fever, vomiting, loss of appetite, irritability, intussusception), and all serious adverse events will be recorded from time of vaccination through Day 56 post vaccination
  • rubella IgG antibody seroconversion [ Time Frame: 8 weeks post vaccination ]
    seroconversion defined as rubella serum IgG antibody concentration >=10 IU/mL 8 weeks post vaccination in a child seronegative pre-vaccination
  • rotavirus IgA and IgG seroresponses [ Time Frame: Day 0 and Day 56 ]
    rotavirus IgA and IgG geometric mean titers (GMT) measured by ELISA before and after concomitant administration of measles-rubella and rotavirus vaccines
  • rotavirus IgA seropositivity [ Time Frame: Day 0 and Day 56 ]
    seroconversion defined as rotavirus serum IgA titer of >=1:20 U/mL measured by ELISA before and after concomitant administration of measles-rubella and rotavirus vaccines


Original Secondary Outcome: Same as current

Information By: PATH

Dates:
Date Received: October 2, 2012
Date Started: January 2013
Date Completion:
Last Updated: May 5, 2014
Last Verified: May 2014