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Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries

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Valneva

Status and phase

Completed
Phase 3

Conditions

Encephalitis

Treatments

Biological: IC51

Study type

Interventional

Funder types

Industry

Identifiers

NCT01047839
IC51-322

Details and patient eligibility

About

The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic

Enrollment

100 patients

Sex

All

Ages

2 months to 17 years old

Volunteers

Accepts Healthy Volunteers

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.
  • The subject is planning to travel to an area where JE is endemic after completion of the vaccination schedule. Exposure to JE should be avoided until 1 week after the second IC51 dose and subjects should return from travel to JE endemic areas before the Month 7 visit. The planned travel to JE endemic areas should not interfere with the study visits and can take place between Visit 2 + 7 days to Month 7.

Exclusion criteria

  • Clinical manifestation or history of any Flavivirus disease
  • Vaccination against JE (except within this protocol), Yellow fever, West Nile virus and Dengue at any time prior or during the study
  • 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 1 week before and 1 week after each IC51 vaccination.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 3 patient groups

>=2 months to <3 years
Experimental group
Description:
IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and 28
Treatment:
Biological: IC51
Biological: IC51
Biological: IC51
>=3 to <12 years
Experimental group
Description:
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
Treatment:
Biological: IC51
Biological: IC51
Biological: IC51
>=12 to <18 years
Experimental group
Description:
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
Treatment:
Biological: IC51
Biological: IC51
Biological: IC51

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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