Clinical Trial: Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella Vaccine

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Immunogenicity and Safety of Concurrent Administration of Live, Attenuated SA 14-14-2 Japanese Encephalitis Vaccine and Measles-Mumps-Rubella Vaccine in Infants 9-12 Months of Age in the Philippines

Brief Summary: This study aims to provide evidence that co-administration of measles-mumps-rubella vaccine (MMR) and live attenuated SA 14-14-2 Japanese encephalitis vaccine (CD-JEV) does not adversely affect immunogenicity or safety.

Detailed Summary: When incorporating a new vaccine in the Expanded Programme on Immunization (EPI), it is important to provide evidence that it can be introduced concurrently with other routine pediatric vaccines without significantly impairing the immune response to any vaccine while maximizing coverage and minimizing cost. This non-inferiority study aims to compare CD-JEV and MMR responses in a population of children in a country where MMR introduction is ongoing or planned. This information will help the ministries of health evaluate the addition of CD-JEV into routine EPI.
Sponsor: PATH

Current Primary Outcome:

  • Measles seropositivity rate [ Time Frame: 56 days after MMR vaccination ]
  • Rubella seropositivity rate [ Time Frame: 56 days after MMR vaccination ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mumps seropositivity rate [ Time Frame: 56 days after MMR vaccination ]
  • Geometric mean neutralizing antibody concentration (GMC) [ Time Frame: 56 days after MMR vaccination ]
  • Anti-mumps Immunoglobulin G (IgG) mean index standard ratio [ Time Frame: 56 days after MMR vaccination ]
  • Anti-rubella IgG GMC [ Time Frame: 56 days after MMR vaccination ]
  • Measles, mumps, and rubella seroconversion rates [ Time Frame: 56 days after MMR vaccination ]
  • Japanese encephalitis seropositivity rate [ Time Frame: 28 days after CD-JEV vaccination ]
  • Anti-Japanese encephalitis neutralizing antibody geometric mean titers [ Time Frame: 28 days after CD-JEV vaccination ]
  • Frequency counts of immediate reactions observed following vaccination [ Time Frame: 30 minutes following each vaccination ]
  • Frequency counts of solicited local and systemic adverse events following vaccination [ Time Frame: 14 days following each vaccination ]
  • Frequency counts of unsolicited adverse events following vaccination [ Time Frame: 28 days following each vaccination ]
  • Frequency counts of serious adverse events following vaccination [ Time Frame: 112 days following first vaccination or until study end (expected to be 8 months) ]


Original Secondary Outcome: Same as current

Information By: PATH

Dates:
Date Received: August 17, 2016
Date Started: October 2016
Date Completion: June 2017
Last Updated: October 18, 2016
Last Verified: August 2016