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Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00595270
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : March 7, 2014
Last Update Posted : March 7, 2014
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Japanese Encephalitis
Intervention Biological: IC51
Enrollment 349
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IC51 2 x 6 µg IC51 1 x 12 µg IC51 1 x 6 µg
Hide Arm/Group Description treatment group in preceeding study IC51-304 treatment group in preceeding study IC51-304 treatment group in preceeding study IC51-304
Period Title: Overall Study
Started 116 117 116
Completed 110 107 108
Not Completed 6 10 8
Arm/Group Title IC51 2 x 6 µg IC51 1 x 12 µg IC51 1 x 6 µg Total
Hide Arm/Group Description treatment group in preceeding study IC51-304 treatment group in preceeding study IC51-304 treatment group in preceeding study IC51-304 Total of all reporting groups
Overall Number of Baseline Participants 116 117 116 349
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 117 participants 116 participants 349 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
109
  94.0%
108
  92.3%
106
  91.4%
323
  92.6%
>=65 years
7
   6.0%
9
   7.7%
10
   8.6%
26
   7.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 117 participants 116 participants 349 participants
Female
67
  57.8%
60
  51.3%
57
  49.1%
184
  52.7%
Male
49
  42.2%
57
  48.7%
59
  50.9%
165
  47.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Europe Number Analyzed 116 participants 117 participants 116 participants 349 participants
116 117 116 349
1.Primary Outcome
Title Long Term Immunogenicity of IC51 Vaccine 24 Months After the Primary Vaccination
Hide Description

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
Time Frame - 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent-To-Treat) Population: included all subjects rolled over from study IC51-304; analyzed according to treatment to which they were randomized in IC51-304
Arm/Group Title IC51 2 x 6 µg IC51 1 x 12 µg IC51 1 x 6 µg
Hide Arm/Group Description:
treatment group in preceeding study IC51-304
treatment group in preceeding study IC51-304
treatment group in preceeding study IC51-304
Overall Number of Participants Analyzed 116 117 116
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
56
(39.4 to 57.3)
7
(3.0 to 11.9)
5
(1.8 to 9.6)
2.Secondary Outcome
Title SPR 24 Months After the Primary Vaccination (Observed)
Hide Description

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)
Time Frame 24 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Persistent and Actual SPR 6, 12 and 24 Months After Primary Vaccination
Hide Description [Not Specified]
Time Frame - 24 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Persistent and Actual GMT 6, 12 and 24 Months After Primary Vaccination
Hide Description [Not Specified]
Time Frame 24 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title SCR 1 Month After the Booster Doses
Hide Description [Not Specified]
Time Frame 1 month
Outcome Measure Data Not Reported
6.Secondary Outcome
Title GMT 1month After Booster Doses
Hide Description [Not Specified]
Time Frame 1 month
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Safety Profile of IC51
Hide Description [Not Specified]
Time Frame study duration
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IC51 2 x 6 µg IC51 1 x 12 µg IC51 1 x 6 µg
Hide Arm/Group Description treatment group in preceeding study IC51-304 treatment group in preceeding study IC51-304 treatment group in preceeding study IC51-304
All-Cause Mortality
IC51 2 x 6 µg IC51 1 x 12 µg IC51 1 x 6 µg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IC51 2 x 6 µg IC51 1 x 12 µg IC51 1 x 6 µg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/116 (3.45%)   4/117 (3.42%)   3/116 (2.59%) 
Infections and infestations       
Appendicitis  1/116 (0.86%)  0/117 (0.00%)  0/116 (0.00%) 
Injury, poisoning and procedural complications       
Facial Bones Fracture  0/116 (0.00%)  1/117 (0.85%)  0/116 (0.00%) 
Hand Fracture  0/116 (0.00%)  0/117 (0.00%)  1/116 (0.86%) 
Tendon Injury  0/116 (0.00%)  1/117 (0.85%)  0/116 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back Pain  0/116 (0.00%)  1/117 (0.85%)  0/116 (0.00%) 
Intervertebral Disc Protrusion  1/116 (0.86%)  0/117 (0.00%)  0/116 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colon Cancer  0/116 (0.00%)  0/117 (0.00%)  1/116 (0.86%) 
Renal and urinary disorders       
Urinary Incontinence  1/116 (0.86%)  0/117 (0.00%)  0/116 (0.00%) 
Reproductive system and breast disorders       
Uterine Prolapse  0/116 (0.00%)  0/117 (0.00%)  1/116 (0.86%) 
Respiratory, thoracic and mediastinal disorders       
Paranasal Sinus Discomfort  1/116 (0.86%)  0/117 (0.00%)  0/116 (0.00%) 
Surgical and medical procedures       
Hysterectomy  0/116 (0.00%)  1/117 (0.85%)  0/116 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
IC51 2 x 6 µg IC51 1 x 12 µg IC51 1 x 6 µg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   61/116 (52.59%)   69/117 (58.97%)   64/116 (55.17%) 
Blood and lymphatic system disorders       
Anaemia  0/116 (0.00%)  0/117 (0.00%)  2/116 (1.72%) 
Lymphadenopathy  2/116 (1.72%)  1/117 (0.85%)  0/116 (0.00%) 
Gastrointestinal disorders       
Diarrhoea  3/116 (2.59%)  3/117 (2.56%)  0/116 (0.00%) 
Nausea  1/116 (0.86%)  6/117 (5.13%)  4/116 (3.45%) 
Toothache  2/116 (1.72%)  1/117 (0.85%)  2/116 (1.72%) 
Vomiting  2/116 (1.72%)  1/117 (0.85%)  1/116 (0.86%) 
Abdominal Pain Upper  1/116 (0.86%)  2/117 (1.71%)  0/116 (0.00%) 
General disorders       
Fatique  5/116 (4.31%)  7/117 (5.98%)  6/116 (5.17%) 
Influenza Like Ilness  7/116 (6.03%)  5/117 (4.27%)  6/116 (5.17%) 
Induration  1/116 (0.86%)  0/117 (0.00%)  2/116 (1.72%) 
Injection Site Pain  0/116 (0.00%)  2/117 (1.71%)  1/116 (0.86%) 
Infections and infestations       
Nasopharyngitis  12/116 (10.34%)  13/117 (11.11%)  11/116 (9.48%) 
Sinusitis  3/116 (2.59%)  0/117 (0.00%)  1/116 (0.86%) 
Herpes Zoster  1/116 (0.86%)  0/117 (0.00%)  2/116 (1.72%) 
Lower Respiratory Tract Infection  2/116 (1.72%)  0/117 (0.00%)  1/116 (0.86%) 
Pharyngitis  0/116 (0.00%)  0/117 (0.00%)  2/116 (1.72%) 
Injury, poisoning and procedural complications       
Accidental Poisoning  1/116 (0.86%)  3/117 (2.56%)  0/116 (0.00%) 
Procedural Pain  1/116 (0.86%)  2/117 (1.71%)  0/116 (0.00%) 
Investigations       
Haematocrit Decreased  0/116 (0.00%)  2/117 (1.71%)  0/116 (0.00%) 
Haemoglobin Decreased  0/116 (0.00%)  2/117 (1.71%)  0/116 (0.00%) 
Red Blood Cell Count Decreased  0/116 (0.00%)  2/117 (1.71%)  0/116 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back Pain  3/116 (2.59%)  4/117 (3.42%)  2/116 (1.72%) 
Myalgia  1/116 (0.86%)  4/117 (3.42%)  5/116 (4.31%) 
Pain In Extremity  2/116 (1.72%)  0/117 (0.00%)  1/116 (0.86%) 
Nervous system disorders       
Headache  10/116 (8.62%)  12/117 (10.26%)  13/116 (11.21%) 
Hypoaesthesia  2/116 (1.72%)  0/117 (0.00%)  0/116 (0.00%) 
Reproductive system and breast disorders       
Dysmenorrhoea  3/116 (2.59%)  1/117 (0.85%)  1/116 (0.86%) 
Respiratory, thoracic and mediastinal disorders       
Cough  5/116 (4.31%)  2/117 (1.71%)  2/116 (1.72%) 
Pharyngolaryngeal Pain  5/116 (4.31%)  5/117 (4.27%)  3/116 (2.59%) 
Rhinorrhoea  1/116 (0.86%)  2/117 (1.71%)  2/116 (1.72%) 
Nasal Congestion  0/116 (0.00%)  2/117 (1.71%)  0/116 (0.00%) 
Sinus Congestion  0/116 (0.00%)  2/117 (1.71%)  0/116 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash  2/116 (1.72%)  2/117 (1.71%)  4/116 (3.45%) 
Eczema  0/116 (0.00%)  0/117 (0.00%)  2/116 (1.72%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Senior Manager Clinical Research
Organization: Intercell AG
Phone: +43 1 206 20 ext 0
Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT00595270     History of Changes
Other Study ID Numbers: IC51-305
First Submitted: January 4, 2008
First Posted: January 16, 2008
Results First Submitted: December 5, 2013
Results First Posted: March 7, 2014
Last Update Posted: March 7, 2014