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

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)

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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