Clinical Trial: Live Attenuated Japanese Encephalitis (JE) Vaccine Coadministered With Measles Vaccine in Infants 9 Months of Age

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

Official Title: Assessment of the Immunogenicity and Safety of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine in Children in Sri Lanka

Brief Summary:

Japanese encephalitis virus is the leading cause of viral neurological disease and disability in Asia. The severity of sequelae, together with the volume of cases, make JE the most important cause of viral encephalitis in the world. Approximately 3 billion people—including 700 million children—live in areas at risk in Asia for JE. JE most commonly infects children between the ages of 1 and 15 years, and can also infect adults in areas where the virus is newly introduced. More than 50,000 cases are reported annually and cause an estimated 10,000 to 15,000 deaths. This figure is believed to represent only a small proportion of the disease burden that actually exists.

Data from a previous trial, also sponsored by PATH and conducted by investigators in the Philippines, indicate that there was no immunologic interference between Japanese encephalitis live attenuated SA 14-14-2 vaccine and measles vaccine when administered at the same time. Additionally, the safety profile of the coadministered vaccines was the same as for the vaccines administered separately. This research study, to be conducted among infants in Sri Lanka, is being done to confirm the Philippines trial results.


Detailed Summary:
Sponsor: PATH

Current Primary Outcome: The proportion of subjects with demonstrated seropositivity for JE and measles at 28 days post coimmunization with live attenuated JE vaccine and measles vaccine.

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Geometric mean titer (GMT) of serum antibody to JE among subjects at 28 days post coimmunization with live attenuated JE vaccine and measles vaccine
  • geometric mean titer (GMT) of serum antibody to measles among subjects at 28 days post coimmunization with live attenuated JE and measles vaccine
  • proportion of subjects with immediate reactions (within 30 minutes after injection, with emphasis on allergic reactions)
  • proportion of subjects with local and systemic reactions (including unsolicited events) measured during the first 7 days following vaccination
  • proportion of subjects with adverse events (AEs) (related or unrelated to vaccination) occurring from Day 8 to Day 28
  • serious adverse events (SAEs) (related or unrelated to vaccination) occurring from Day 0 to Day 365
  • the proportion of subjects with demonstrated seropositivity for JE and measles at 365 days post coimmunization with live attenuated JE vaccine and measles vaccine
  • geometric mean titer (GMT) of serum antibody to JE among subjects at 365 days post coimmunization with live attenuated JE vaccine and measles vaccine
  • geometric mean titer (GMT) of serum antibody to measles among subjects at 365 days post coimmunization with live attenuated JE and measles vaccine


Original Secondary Outcome: Same as current

Information By: PATH

Dates:
Date Received: April 18, 2007
Date Started: July 2007
Date Completion:
Last Updated: May 4, 2009
Last Verified: April 2009