Clinical Trial: Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children

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

Official Title: Single-blind, Randomized, Phase 3B Study in Children Aged 1 - 11 Years to Investigate the Immunogenicity, Safety and Interchangeability of Two Tick-borne Encephalitis (Tbe

Brief Summary: The objective of this study is to assess the immunogenicity, safety and interchangeability of two different TBE vaccines in children aged 1-11 years, the first and second vaccination with either FSME-IMMUN 0.25ml Junior or Encepur 0.25ml Children and the third vaccination with FSME-IMMUN 0.25 ml Junior only, administered according to the conventional schedule (0, 28 and 360 days).

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: Seropositivity rate as determined by neutralization test (NT) 28 days after the second vaccination [ Time Frame: 28 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Seropositivity rate determined by NT 180 days after the first vaccination and 28 days after the third vaccination [ Time Frame: 28, 180 days ]
  • Seropositivity rate determined by ELISA 28 days after the second vaccination, 180 days after the first vaccination and 28 days after the third vaccination [ Time Frame: 28, 180 days ]
  • Antibody response measured by NT/ELISA 28 days after the second vaccination, 180 days after the first vaccination and 28 days after the third vaccination [ Time Frame: 28, 180 days ]
  • Fold increase of antibody response measured by NT/ELISA 28 days after the second vaccination, 180 days after the first vaccination and 28 days after the third vaccination as compared to baseline [ Time Frame: 28, 180 days ]
  • Frequency and severity of injection site reactions/systemic reactions occurring after each vaccination [ Time Frame: 28 days ]
  • Frequency and severity of adverse experiences (AEs) observed during the entire follow-up period [ Time Frame: 388 days ]


Original Secondary Outcome: Same as current

Information By: Pfizer

Dates:
Date Received: February 9, 2009
Date Started: February 2009
Date Completion:
Last Updated: May 20, 2015
Last Verified: May 2015