Clinical Trial: Tick-Borne Encephalitis (TBE) Seropersistence After First Booster in Children, Adolescents and Young Adults (Follow-Up to Study 700401)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Open-label Phase Iv Study To Investigate The Seropersistence Of Tick-borne Encephalitis (Tbe) Virus Antibodies After The First Booster And The Response To A Second Booster

Brief Summary: The main purpose of this study is to assess the seropersistence of TBE virus antibodies in children, adolescents and young adults who received the first booster vaccination with either FSME-IMMUN 0.25 mL Junior or FSME-IMMUN 0.5 mL in precursor Study 700401.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: Seropositivity rate determined by neutralization test (NT) after the first booster vaccination administered in Study 700401 and after the second booster vaccination administered in this study [ Time Frame: At yearly intervals from approximately 3 years (38 months) to 10 years (118 months) after the first booster vaccination ]

Original Primary Outcome: Seropositivity rate as determined by neutralization test (NT) at 38, 46 and 58 months after the first booster vaccination administered in Study 700401 and after the second booster vaccination administered in this study [ Time Frame: 38, 46 and 58 months after first booster vaccination ]

Current Secondary Outcome:

  • Seropositivity rate determined by ELISA after the first booster vaccination administered in Study 700401 and after the second booster vaccination administered in this study [ Time Frame: At yearly intervals from approximately 3 years (38 months) to 10 years (118 months) after the first booster vaccination ]
  • Antibody response determined by ELISA after the first booster vaccination administered in Study 700401 and after the second booster vaccination administered in this study [ Time Frame: At yearly intervals from approximately 3 years (38 months) to 10 years (118 months) after the first booster vaccination ]
  • Antibody response determined by neutralization test (NT) after the first booster vaccination administered in Study 700401 and after the second booster vaccination administered in this study [ Time Frame: At yearly intervals from approximately 3 years (38 months) to 10 years (118 months) after the first booster vaccination ]
  • Fold increase of antibody concentration determined by ELISA after the second booster vaccination as compared to before the second booster vaccination in this study [ Time Frame: 21-35 days after the booster vaccination ]
  • Fold increase of antibody concentration determined by neutralization test (NT) after the second booster vaccination as compared to before the second booster vaccination in this study [ Time Frame: 21-35 days after the booster vaccination ]
  • Injection site reactions observed in the period from the second booster vaccination until the following blood draw [ Time Frame: 21-35 days after the booster vaccination ]
  • Systemic reactions observed in the period from the second booster vaccination until the following blood draw [ Time Frame: 21-35 days after the booster vaccination ]


Original Secondary Outcome:

Information By: Pfizer

Dates:
Date Received: April 30, 2009
Date Started: April 2009
Date Completion: July 2017
Last Updated: April 5, 2017
Last Verified: April 2017