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

NCT ID: NCT01041573

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1869 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-07-31

Brief Summary

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.

Detailed 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.

Conditions

Encephalitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

IC51 0.5 mL

Japanese Encephalitis Vaccine 6mcg im. at day 0 and day 28

Group Type: EXPERIMENTAL

IC51 Japanese Encephalitis

Intervention Type: BIOLOGICAL

6 mcg or 3 mcg im. at day 0 and day 28

IC51 0.25 mL

Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28

Group Type: EXPERIMENTAL

IC51 Japanese Encephalitis

Intervention Type: BIOLOGICAL

6 mcg or 3 mcg im. at day 0 and day 28

Havrix 720

Havrix®720 0.5 ml im. at day 0 and month 7

Group Type: ACTIVE_COMPARATOR

Havrix®720

Intervention Type: BIOLOGICAL

0.5 ml im. at day 0 and month 7

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

Group Type: ACTIVE_COMPARATOR

Prevnar

Intervention Type: BIOLOGICAL

0.5 ml im. at day 0 and day 56 and month 7

Interventions

IC51 Japanese Encephalitis

6 mcg or 3 mcg im. at day 0 and day 28

Intervention Type: BIOLOGICAL

Havrix®720

0.5 ml im. at day 0 and month 7

Intervention Type: BIOLOGICAL

Prevnar

0.5 ml im. at day 0 and day 56 and month 7

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Valneva Austria GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vera Kadlecek

Role: STUDY_DIRECTOR

Valneva Austria GmbH

Locations

Research Institute for Tropical Medicine

City of Muntinlupa, Filinvest Corporate City, Philippines

Department of Pediatrics, UP-Philippine General Hospital

Manila, , Philippines

Countries

Philippines

Other Identifiers

IC51-323

Identifier Type: -

Identifier Source: org_study_id