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Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01041573
First Posted: December 31, 2009
Last Update Posted: May 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Valneva Austria GmbH
December 30, 2009
December 31, 2009
January 16, 2014
February 27, 2014
May 6, 2016
March 2010
February 2011   (Final data collection date for primary outcome measure)
Rate of Subjects With Serious Adverse Events and Medically Attended Adverse Events Until Day 56 After First Vaccination [ Time Frame: until Day 56 ]
Comparing study participants 1 year and above receiving IC51 0.25mL, IC51 0.5 mL and Havrix
Rate of subjects with serious adverse events and medically attended adverse events until Day 56 [ Time Frame: until Day 56 ]
Complete list of historical versions of study NCT01041573 on ClinicalTrials.gov Archive Site
  • Geometric Mean Titers (GMT) for JEV Neutralizing Antibodies and SCR at Days 0, 56 and at Month 7 [ Time Frame: Day 0, 56 and at Month 7 ]
  • Rate of Subjects With SAEs and Medically Attended AEs up to Month 7 [ Time Frame: up to Month 7 ]
  • Rate of Subjects With Solicited Local and Systemic AEs [ Time Frame: study duration ]
  • Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 [ Time Frame: Day 56 and up to Month 7 ]
  • Rate of Subjects With Abnormal Laboratory Parameters [ Time Frame: study duration ]
Same as current
Not Provided
Not Provided
 
Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population
Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population. Open Label, Randomized, Active Controlled, Phase 3 Study
The primary objective is to assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51 administered in two doses in a 28 days interval up to Month 7 after the first IC51 vaccination in a pediatric population from endemic regions.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Encephalitis
  • Biological: IC51 Japanese Encephalitis
    6 mcg or 3 mcg im. at day 0 and day 28
  • Biological: Havrix®720
    0.5 ml im. at day 0 and month 7
  • Biological: Prevnar
    0.5 ml im. at day 0 and day 56 and month 7
  • Experimental: IC51 0.5 mL
    Japanese Encephalitis Vaccine 6mcg im. at day 0 and day 28
    Intervention: Biological: IC51 Japanese Encephalitis
  • Experimental: IC51 0.25 mL
    Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28
    Intervention: Biological: IC51 Japanese Encephalitis
  • Active Comparator: Havrix 720
    Havrix®720 0.5 ml im. at day 0 and month 7
    Intervention: Biological: Havrix®720
  • Active Comparator: Prevnar
    Prevnar 0.5 ml im. at day 0 and day 56 and month 7 or 0.5 ml im. at day 0, day 28 and day56 and month 7-13
    Intervention: Biological: Prevnar
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1869
July 2011
February 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female healthy children and adolescents aged > 2 months to < 18 years at the time of first vaccination.
  • Written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable.
  • Female subjects: either no childbearing potential or negative pregnancy test, for females after menarche willingness to practice a reliable method of contraception.

Exclusion Criteria:

  • Clinical manifestation of Japanese Encephalitis
  • History of Flavivirus vaccination (including any investigational vaccines)
  • History of vaccination with HAVRIX®720 and/or Prevnar®
  • History of immunodeficiency or immunosuppressive therapy
  • Known HIV, HBV or HCV infection
  • History of hypersensitivity reactions to other vaccines
  • Acute febrile infection at each visit during which the subject receives a vaccination
  • Active or passive immunization within 2 weeks prior to the first IC51 vaccination and up to the second IC51 vaccination.
Sexes Eligible for Study: All
2 Months to 18 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Philippines
Malaysia
 
NCT01041573
IC51-323
Yes
Not Provided
Not Provided
Valneva Austria GmbH
Valneva Austria GmbH
Not Provided
Study Director: Vera Kadlecek Valneva Austria GmbH
Valneva Austria GmbH
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP