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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00595270
Other study ID # IC51-305
Secondary ID
Status Completed
Phase Phase 3
First received January 4, 2008
Last updated February 5, 2014
Start date October 2005
Est. completion date April 2009

Study information

Verified date February 2014
Source Valneva Austria GmbH
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-InstitutUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The study investigates the long term persistence the Japanese encephalitis vaccine IC51 and the need of a booster dose


Description:

This is an open label, non‐randomized multi‐center phase 3 follow‐up study. All volunteers having completed trial IC51‐304 (NCT00595790) will be enrolled into this trial at 2 sites


Recruitment information / eligibility

Status Completed
Enrollment 349
Est. completion date April 2009
Est. primary completion date September 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- At least 18 years of age

- Written informed consent obtained prior to study entry

- Subjects correctly included in and having completed study IC51-304 according to the protocol.

Exclusion Criteria:

- Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period

- Immunodeficiency including post-organ-transplantation or immunosuppressive therapy

- Pregnancy, lactation or unreliable contraception in female subjects

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Biological:
IC51


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Valneva Austria GmbH

Outcome

Type Measure Description Time frame Safety issue
Primary Long Term Immunogenicity of IC51 Vaccine 24 Months After the Primary Vaccination Seroprotection rate (SPR) (anti-JEV neutralizing antibody titer = 1:10) 24 months (M24) after the primary vaccination - imputed; Persistence of immunogenicity (SPR) at M24 defined as:
pos. (positive) (persistent): Subjects
with a non-missing, pos. seroconversion at D56 (Study IC51-304) and
without booster at M11 or M23 and
with non-missing, seroprotection (SP) pos. PRNT50 at M6 or M12 and
with non-missing, SP pos. PRNT50 at M24
neg. (negative) (non-persistent): Subjects with
missing or neg. seroconversion at D56 (Study IC51-304) or
booster at M11 or at M23, or
non-missing, SP neg. PRNT50 at M6 or M12 or
missing PRNT50 at both M6 and M12 or
missing or SP neg. PRNT50 (serum dilution giving 50% reduction in plaques in a Plaque Reduction Neutralization Test) at M24
- 24 months No
Secondary SPR 24 Months After the Primary Vaccination (Observed) Persistence of immunogenicity (SPR) at M24 (observed) defined as :
positive (persistent): Subjects
with a non-missing, positive seroconversion at D56 (Study IC51-304), and
who did not receive a booster dose at Visit 2 (M11) or Visit 4 (M23), and
with a non-missing, SP positive PRNT50 result at Visit 1 (M6) or Visit 3 (M12), and
with a non-missing, SP positive PRNT50 result at Visit 5 (M24)
negative (non-persistent): Subjects
with missing or negative seroconversion at D56 (Study IC51-304), or
who did receive a booster dose at Visit 2 (M11) or at Visit 4 (M23), or
with a non-missing, SP negative PRNT50 result at Visit 1 (M6) or Visit 3 (M12), or
with a missing PRNT50 result at both Visit 1 (M6) and Visit 3 (M12), or
with a non-missing, SP negative PRNT50 result at Visit 5 (M24)
24 months No
Secondary Persistent and Actual SPR 6, 12 and 24 Months After Primary Vaccination - 24 months No
Secondary Persistent and Actual GMT 6, 12 and 24 Months After Primary Vaccination 24 months No
Secondary SCR 1 Month After the Booster Doses 1 month No
Secondary GMT 1month After Booster Doses 1 month No
Secondary Safety Profile of IC51 study duration Yes
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