Text Size
Trial record 8 of 252 for:    Encephalitis
Previous Study | Return to List | Next Study

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):
Intercell AG
ClinicalTrials.gov Identifier:
NCT01041573
First received: December 30, 2009
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  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:

MedlinePlus related topics: Encephalitis
U.S. FDA Resources

Further study details as provided by Intercell AG:

Primary Outcome Measures:
  • Rate of subjects with serious adverse events and medically attended adverse events until Day 56 [ Time Frame: until Day 56 ] [ Designated as safety issue: Yes ]

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: Yes ]
  • 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: November 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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: 2
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: 3
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: 4
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
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
Intercell AG
Investigators
Study Director: Vera Kadlecek Intercell AG
  More Information

No publications provided

Responsible Party: Intercell AG
ClinicalTrials.gov Identifier: NCT01041573     History of Changes
Other Study ID Numbers: IC51-323
Study First Received: December 30, 2009
Last Updated: March 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Intercell AG:
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 May 16, 2013