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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT01041573
First received: December 30, 2009
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Encephalitis
Biological: IC51 Japanese Encephalitis
Biological: Havrix®720
Biological: Prevnar
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population. Open Label, Randomized, Active Controlled, Phase 3 Study

Resource links provided by NLM:


Further study details as provided by Valneva Austria GmbH:

Primary Outcome Measures:
  • Rate of Subjects With Serious Adverse Events and Medically Attended Adverse Events Until Day 56 After First Vaccination [ Time Frame: until Day 56 ] [ Designated as safety issue: Yes ]
    Comparing study participants 1 year and above receiving IC51 0.25mL, IC51 0.5 mL and Havrix


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Rate of Subjects With SAEs and Medically Attended AEs up to Month 7 [ Time Frame: up to Month 7 ] [ Designated as safety issue: Yes ]
  • Rate of Subjects With Solicited Local and Systemic AEs [ Time Frame: study duration ] [ Designated as safety issue: Yes ]
  • Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 [ Time Frame: Day 56 and up to Month 7 ] [ Designated as safety issue: Yes ]
  • Rate of Subjects With Abnormal Laboratory Parameters [ Time Frame: study duration ] [ Designated as safety issue: Yes ]

Enrollment: 1869
Study Start Date: March 2010
Study Completion Date: July 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IC51 0.5 mL
Japanese Encephalitis Vaccine 6mcg im. at day 0 and day 28
Biological: IC51 Japanese Encephalitis
6 mcg or 3 mcg im. at day 0 and day 28
Experimental: IC51 0.25 mL
Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28
Biological: IC51 Japanese Encephalitis
6 mcg or 3 mcg im. at day 0 and day 28
Active Comparator: Havrix 720
Havrix®720 0.5 ml im. at day 0 and month 7
Biological: Havrix®720
0.5 ml im. at day 0 and month 7
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
Biological: Prevnar
0.5 ml im. at day 0 and day 56 and month 7

  Eligibility

Ages Eligible for Study:   2 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01041573

Locations
Philippines
Research Institute for Tropical Medicine
Alabang Muninlupa City, Philippines, 1781
Department of Pediatrics, UP-Philippine General Hospital
Manila, Philippines, 1000
Sponsors and Collaborators
Valneva Austria GmbH
Investigators
Study Director: Vera Kadlecek Valneva Austria GmbH
  More Information

No publications provided

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT01041573     History of Changes
Other Study ID Numbers: IC51-323
Study First Received: December 30, 2009
Results First Received: January 16, 2014
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Valneva Austria GmbH:
Pediatric
Japanese Encephalitis Vaccine
endemic countries
to assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Encephalitis, Arbovirus
Encephalitis, Viral
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Arbovirus Infections
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on September 18, 2014