Clinical trial NCT01041573: Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population
Official title: Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population. Open Label, Randomized, Active Controlled, Phase 3 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Encephalitis
Keywords: Pediatric
Japanese Encephalitis Vaccine
endemic countries
to assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51
Lead sponsor: Valneva Austria GmbH
Sponsor class: INDUSTRY
First posted: 2009-12-31
Enrollment: 1869
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Rate of Subjects With Serious Adverse Events and Medically Attended Adverse Events Until Day 56 After First Vaccination
timeFrame: until Day 56
Secondary outcomes:
measure: Geometric Mean Titers (GMT) for JEV Neutralizing Antibodies
timeFrame: Day 0, 56 and at Month 7
measure: Seroconversion Rate (SCR) at Days 0, 56 and at Month 7
timeFrame: Days 0, 56 and at Month 7
measure: Rate of Subjects With SAEs and Medically Attended AEs
timeFrame: up to Month 7
measure: Rate of Subjects With Solicited Local and Systemic AEs
timeFrame: 7 days post vaccination
measure: Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7
timeFrame: Day 56 and up to Month 7
measure: Rate of Subjects With Abnormal Laboratory Parameters
timeFrame: Day 56 and Month 7
Other outcomes:
Locations:
city: Muntinlupa
country: Philippines
facility: Research Institute for Tropical Medicine
state: Filinvest Corporate City
city: Manila
country: Philippines
facility: Department of Pediatrics, UP-Philippine General Hospital
Study officials:
affiliation: Valneva Austria GmbH
name: Vera Kadlecek
role: STUDY_DIRECTOR
References: