Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51
Sponsor
Valneva Austria GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT00596102
Collaborator
(none)
3,258
Study Details
Study Description
Brief Summary
The study investigates the long term safety and immunogenicity of the Japanese Encephalitis vaccine IC51 up to month 60.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
3258 participants
Observational Model:
Cohort
Official Title:
Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51. An Uncontrolled Phase 3 Follow-up Study
Study Start Date
:
Oct 1, 2005
Actual Primary Completion Date
:
Mar 1, 2011
Outcome Measures
Primary Outcome Measures
- Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) [24 months after the first vaccination]
first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302
Secondary Outcome Measures
- Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) [6, 12, 36, 48 and 60 months after 1st vaccination]
- Geometric Mean Titers [6, 12, 36, 48 and 60 months]
- Adverse Events [6, 12, 24, 36, 48 and 60 months after 1st vaccination]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Healthy subjects at least 18 years of age
-
Written informed consent obtained prior to study entry
-
Subjects correctly included and having completed clinical studies IC51-301 (NCT00604708) and IC51-302 (NCT00605085) with at least one vaccination
Exclusion Criteria:
- Inability or unwillingness to provide informed consent and to abide the requirements of the study
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Valneva Austria GmbH
Investigators
- Study Director: Evelyn Hatzenbichler, Ph.D., Valneva Austria GmbH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT00596102
Other Study ID Numbers:
- IC51-303
First Posted:
Jan 16, 2008
Last Update Posted:
Jul 30, 2014
Last Verified:
Jun 1, 2014
Study Results
Participant Flow
| Recruitment Details | study participants were recruited from 44 study centers previously participating in study IC51-301 and IC51-302 |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | IC51 | JE-VAX | Placebo |
|---|---|---|---|
| Arm/Group Description | no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302 | no active treatment in study IC51-303, vaccinations were performed in preceeding study IC51-301 | no treatment in study IC51-303, vaccinations were performed in preceeding study IC51-302 |
| Period Title: Up to Month 6 | |||
| STARTED | 2283 | 338 | 637 |
| COMPLETED | 2283 | 338 | 637 |
| NOT COMPLETED | 0 | 0 | 0 |
| Period Title: Up to Month 6 | |||
| STARTED | 2283 | 338 | 637 |
| COMPLETED | 102 | 0 | 0 |
| NOT COMPLETED | 2181 | 338 | 637 |
Baseline Characteristics
| Arm/Group Title | IC51 | JE-VAX | Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302 | no active treatment in study IC51-303, vaccinations were performed in preceeding study IC51-301 | no treatment in study IC51-303, vaccinations were performed in preceeding study IC51-302 | Total of all reporting groups |
| Overall Participants | 2283 | 338 | 637 | 3258 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
35.3
(13.8)
|
42.3
(14.1)
|
33.5
(13.0)
|
35.6
(13.9)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
1274
55.8%
|
201
59.5%
|
365
57.3%
|
1840
56.5%
|
| Male |
1009
44.2%
|
137
40.5%
|
272
42.7%
|
1418
43.5%
|
| Race/Ethnicity, Customized (participants) [Number] | ||||
| Asian |
38
1.7%
|
1
0.3%
|
16
2.5%
|
55
1.7%
|
| Black or African American |
101
4.4%
|
35
10.4%
|
25
3.9%
|
161
4.9%
|
| Caucasian |
2076
90.9%
|
288
85.2%
|
574
90.1%
|
2938
90.2%
|
| Other |
68
3%
|
14
4.1%
|
22
3.5%
|
104
3.2%
|
Outcome Measures
| Title | Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) |
|---|---|
| Description | first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302 |
| Time Frame | 24 months after the first vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| subjects enrolled into this study who planned to participate in the long-term immunogenicity part and received IC51 in the respective preceeding study |
| Arm/Group Title | IC51 |
|---|---|
| Arm/Group Description | no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302 |
| Measure Participants | 181 |
| Number (95% Confidence Interval) [percentage of subjects] |
81.8
|
| Title | Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) |
|---|---|
| Description | |
| Time Frame | 6, 12, 36, 48 and 60 months after 1st vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Geometric Mean Titers |
|---|---|
| Description | |
| Time Frame | 6, 12, 36, 48 and 60 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Adverse Events |
|---|---|
| Description | |
| Time Frame | 6, 12, 24, 36, 48 and 60 months after 1st vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60 | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60") | |||||||
| Arm/Group Title | IC51 Month 6 | JE-VAX | Placebo | IC51 Month 60 | ||||
| Arm/Group Description | no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6 | no active treatment in study IC51-303, JE-VAX vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6 | no active treatment in study IC51-303, Plarcebo vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6 | no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 60 | ||||
All Cause Mortality |
||||||||
| IC51 Month 6 | JE-VAX | Placebo | IC51 Month 60 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| IC51 Month 6 | JE-VAX | Placebo | IC51 Month 60 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/2283 (0.7%) | 2/338 (0.6%) | 7/637 (1.1%) | 14/102 (13.7%) | ||||
| Cardiac disorders | ||||||||
| Coronary Stenosis | 0/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 1/102 (1%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal Pain | 1/2283 (0%) | 0/338 (0%) | 1/637 (0.2%) | 0/102 (0%) | ||||
| Abdominal Pain Lower | 1/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 0/102 (0%) | ||||
| Appendix Disorder | 1/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 0/102 (0%) | ||||
| Vomiting | 0/2283 (0%) | 1/338 (0.3%) | 0/637 (0%) | 0/102 (0%) | ||||
| Infections and infestations | ||||||||
| Appendiceal Abscess | 1/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 0/102 (0%) | ||||
| Appendicitis | 0/2283 (0%) | 0/338 (0%) | 1/637 (0.2%) | 0/102 (0%) | ||||
| Diverticulitis | 1/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 0/102 (0%) | ||||
| Pneumonia | 0/2283 (0%) | 0/338 (0%) | 1/637 (0.2%) | 0/102 (0%) | ||||
| Pyelonephritis | 1/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 0/102 (0%) | ||||
| Sepsis | 0/2283 (0%) | 0/338 (0%) | 1/637 (0.2%) | 0/102 (0%) | ||||
| Abscess Soft Tissue | 0/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 1/102 (1%) | ||||
| Endometritis | 0/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 1/102 (1%) | ||||
| Tonsillitis | 0/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 1/102 (1%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Head Injury | 1/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 0/102 (0%) | ||||
| Joint Ligament Rupture | 1/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 0/102 (0%) | ||||
| Tibia Fructure | 1/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 0/102 (0%) | ||||
| Lower Limb Fracture | 0/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 2/102 (2%) | ||||
| Investigations | ||||||||
| Smear Cervix Abnormal | 0/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 1/102 (1%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Rhabdomyolysis | 0/2283 (0%) | 0/338 (0%) | 1/637 (0.2%) | 0/102 (0%) | ||||
| Synovial Cyst | 0/2283 (0%) | 0/338 (0%) | 1/637 (0.2%) | 0/102 (0%) | ||||
| Shoulder Pain | 0/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 2/102 (2%) | ||||
| Toe Deformity | 0/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 1/102 (1%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Adenocarinoma Pancreas | 1/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 0/102 (0%) | ||||
| Breast Cancer | 1/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 0/102 (0%) | ||||
| Lung Adenocarcinoma Metastatic | 1/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 0/102 (0%) | ||||
| Prostate Cancer | 0/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 1/102 (1%) | ||||
| Nervous system disorders | ||||||||
| Central Nervous System Inflammation | 1/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 0/102 (0%) | ||||
| Post Herpetic Neuralgia | 0/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 1/102 (1%) | ||||
| Pregnancy, puerperium and perinatal conditions | ||||||||
| Ectopic Pregnancy | 1/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 0/102 (0%) | ||||
| Renal and urinary disorders | ||||||||
| Nephrolithiasis | 1/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 0/102 (0%) | ||||
| Urethral Stricture | 0/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 1/102 (1%) | ||||
| Reproductive system and breast disorders | ||||||||
| Ovarian Cyst | 0/2283 (0%) | 0/338 (0%) | 1/637 (0.2%) | 0/102 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Mediastinal Mass | 1/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 0/102 (0%) | ||||
| Nasal Septum Deviation | 0/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 1/102 (1%) | ||||
| Social circumstances | ||||||||
| Blood Donor | 0/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 1/102 (1%) | ||||
| Surgical and medical procedures | ||||||||
| Meniscus Operation | 0/2283 (0%) | 0/338 (0%) | 1/637 (0.2%) | 0/102 (0%) | ||||
| Tonsillectomy | 0/2283 (0%) | 1/338 (0.3%) | 0/637 (0%) | 1/102 (1%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| IC51 Month 6 | JE-VAX | Placebo | IC51 Month 60 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 78/2283 (3.4%) | 16/338 (4.7%) | 31/637 (4.9%) | 54/102 (52.9%) | ||||
| Endocrine disorders | ||||||||
| Hypothyroidism | 0/2283 (0%) | 2/338 (0.6%) | 0/637 (0%) | 3/102 (2.9%) | ||||
| Gastrointestinal disorders | ||||||||
| Diarrhoea | 10/2283 (0.4%) | 0/338 (0%) | 3/637 (0.5%) | 3/102 (2.9%) | ||||
| Infections and infestations | ||||||||
| Nasopharyngitis | 78/2283 (3.4%) | 16/338 (4.7%) | 31/637 (4.9%) | 19/102 (18.6%) | ||||
| Acute Tonsillitis | 6/2283 (0.3%) | 4/338 (1.2%) | 1/637 (0.2%) | 3/102 (2.9%) | ||||
| Bronchitis | 13/2283 (0.6%) | 2/338 (0.6%) | 4/637 (0.6%) | 6/102 (5.9%) | ||||
| Cystitis | 11/2283 (0.5%) | 0/338 (0%) | 3/637 (0.5%) | 7/102 (6.9%) | ||||
| Herpes Simplex | 3/2283 (0.1%) | 0/338 (0%) | 1/637 (0.2%) | 3/102 (2.9%) | ||||
| Pneumonia | 4/2283 (0.2%) | 0/338 (0%) | 2/637 (0.3%) | 3/102 (2.9%) | ||||
| Pyelonephritis | 1/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 3/102 (2.9%) | ||||
| Tonsillitis | 6/2283 (0.3%) | 0/338 (0%) | 0/637 (0%) | 2/102 (2%) | ||||
| Urinary Tract Infection | 17/2283 (0.7%) | 2/338 (0.6%) | 6/637 (0.9%) | 4/102 (3.9%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Upper Limb Fracture | 0/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 3/102 (2.9%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 6/2283 (0.3%) | 0/338 (0%) | 3/637 (0.5%) | 4/102 (3.9%) | ||||
| Back Pain | 13/2283 (0.6%) | 1/338 (0.3%) | 3/637 (0.5%) | 3/102 (2.9%) | ||||
| Shoulder Pain | 6/2283 (0.3%) | 0/338 (0%) | 3/637 (0.5%) | 3/102 (2.9%) | ||||
| Nervous system disorders | ||||||||
| Headache | 42/2283 (1.8%) | 1/338 (0.3%) | 7/637 (1.1%) | 4/102 (3.9%) | ||||
| Psychiatric disorders | ||||||||
| Depression | 5/2283 (0.2%) | 2/338 (0.6%) | 0/637 (0%) | 4/102 (3.9%) | ||||
| Surgical and medical procedures | ||||||||
| Dental Implantation | 1/2283 (0%) | 0/338 (0%) | 0/637 (0%) | 3/102 (2.9%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Katrin Dubischar-Kastner |
|---|---|
| Organization | Valneva Austria GmbH |
| Phone | +43 1 20620 ext 0 |
| info@valneva.com |
Responsible Party:
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT00596102
Other Study ID Numbers:
- IC51-303
First Posted:
Jan 16, 2008
Last Update Posted:
Jul 30, 2014
Last Verified:
Jun 1, 2014