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

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Valneva

Status and phase

Completed
Phase 3

Conditions

Encephalitis

Treatments

Biological: Prevnar
Biological: Havrix®720
Biological: IC51 Japanese Encephalitis

Study type

Interventional

Funder types

Industry

Identifiers

NCT01041573
IC51-323

Details and patient eligibility

About

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.

Full description

Open-label, randomized, active controlled Phase 3 study in children aged ≥ 2 months to < 18 years. Subjects aged ≥ 2 months to < 12 months were randomized in a 2:1 ratio to receive IC51 (0.25 ml dose) or Prevnar® as a safety comparator. Children aged ≥ 12 months to < 3 years and ≥ 12 years to < 18 years were randomized in a 3:1 ratio to receive IC51 (0.25 ml dose < 3 years, 0.5 ml ≥ 12 years) or HAVRIX®720 as safety comparator.

For subjects aged ≥ 3 years to < 12 years, a dose finding run-in phase was performed. A total of 200 subjects were randomized 1:1 to receive either the 0.25 ml or the 0.5 ml dose of IC51, and the appropriate dose was determined based on an interim analysis. After this run-in phase, 300 further children in this age group were randomized 2:1 to receive either 0.5 ml of IC51 or HAVRIX®720.

Immunogenicity was be studied in a subgroup of 30 children aged ≥ 2 months to < 12 months; 125 children aged ≥ 12 months to < 3 years and 140 children ≥ 12 years to < 18 years. For the age group of ≥ 3 to < 12 years immunogenicity was assessed in the 200 children enrolled during the dose-finding run-in phase.

Enrollment

1,869 patients

Sex

All

Ages

2 months to 18 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.

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,869 participants in 4 patient groups

IC51 0.5 mL
Experimental group
Description:
Japanese Encephalitis Vaccine 6mcg im. at day 0 and day 28
Treatment:
Biological: IC51 Japanese Encephalitis
IC51 0.25 mL
Experimental group
Description:
Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28
Treatment:
Biological: IC51 Japanese Encephalitis
Havrix 720
Active Comparator group
Description:
Havrix®720 0.5 ml im. at day 0 and month 7
Treatment:
Biological: Havrix®720
Prevnar
Active Comparator group
Description:
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
Treatment:
Biological: Prevnar

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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