## Protocol Section
### Identification Module
**NCT ID:** NCT01246479

**Brief Title:** Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study

**Official Title:** Long Term Immunity and Safety Following Vaccination With the Japanese Encephalitis Vaccine IC51(IXIARO®, JESPECT®) In a Pediatric Population in Non Endemic Countries. Uncontrolled, Phase 3 Follow-up Study

#### Organization Study ID Info
**ID:** IC51-324
#### Organization
**Class:** INDUSTRY
**Full Name:** Valneva Austria GmbH
### Status Module
#### Completion Date
**Date:** 2014-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-03-18

**Type:** ACTUAL

**Last Update Submit Date:** 2020-03-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-10

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2015-04-29

**Type:** ESTIMATED

**Results First Submit Date:** 2015-04-13

**Results First Submit QC Date:** 2015-04-13

#### Start Date
**Date:** 2010-10

**Status Verified Date:** 2020-03

#### Study First Post Date
**Date:** 2010-11-23
**Type:** ESTIMATED
**Study First Submit Date:** 2010-10-06
**Study First Submit QC Date:** 2010-11-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Valneva Austria GmbH

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The study investigates long-term immunity and safety of IC51 (IXIARO®, JESPECT®) in a pediatric population vaccinated in the parent study IC51-322.

### Conditions Module

**Conditions:**

- Japanese Encephalitis

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 23

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** subjects will be followed up on immunity (analysis of blood samples) and safety

**Intervention Names:**

- Procedure: Blood draw

- Biological: IC51 has given in the parent study IC51-322

**Label:** No treatment

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- No treatment

**Description:** blood draw at Month 12, Month 24 and Month 36.

**Name:** Blood draw

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- No treatment

**Description:** No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.

**Name:** IC51 has given in the parent study IC51-322

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** Rate of subjects with PRNT50 titers of ≥ 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322)

**Measure:** Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Month 12 After the First IC51 Vaccination (in Study IC51-322)

**Time Frame:** Month 12

#### Secondary Outcomes

**Description:** GMT for JEV neutralizing antibodies measured using the PRNT at Month 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)

**Measure:** GMT for JEV Neutralizing Antibodies Measured Using the PRNT at Month 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322)

**Time Frame:** Month 12, 24 and 36

**Description:** Rate of subjects with PRNT50 titers of ≥ 1:10 at Months 24 and 36 after the first IC51 vaccination (in study IC51-322)

**Measure:** Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Months 24 and 36 After the First IC51 Vaccination (in Study IC51-322)

**Time Frame:** Month 24, 36

**Description:** Rate of subjects with SAEs following immunization up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)

**Measure:** Rate of Subjects With SAEs Following Immunization up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322)

**Time Frame:** Months 12, 24 and 36

**Description:** Rate of subjects with AEs and medically attended AEs up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322).

**Measure:** Rate of Subjects With AEs and Medically Attended AEs up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322).

**Time Frame:** Months 12, 24 and 36

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subjects who have received two vaccinations in study IC51 322. (2) Subjects who were enrolled as part of the immunogenicity subgroup of study IC51-322.
* Male or female healthy subjects aged ≥ 9 months to \< 21 years at the time of enrolment into this study.
* Written informed consent by the subject, the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable.

Exclusion Criteria:

* History of or clinical manifestation of any Flavivirus disease during study IC51-322.
* Vaccination against JE virus (JEV) (except with IC51) at any time prior or planned during this study.
* Participation in another study with an investigational product during study IC51-322 or IC51-324.
* History of or development of any immunodeficiency including post-organtransplantation after inclusion into study IC51-322.
* History of or development of an autoimmune disease during study IC51-322.
* Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying medications started during study IC51-322 up to first visit of study IC51-324. (For corticosteroids this means prednisone or equivalent at \>= 0.05 mg/kg/day. Topical or inhaled steroids are allowed).
* Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
* Illicit drug use and/or a history of drug or alcohol addiction and/or current drug or alcohol addiction.
* Inability or unwillingness by the legal representative(s) and/or the subject (where applicable) to provide informed consent/assent and to abide by the requirements of the study.
* Persons who are committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).

**Healthy Volunteers:** True

**Maximum Age:** 20 Years

**Minimum Age:** 9 Months

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tampa

**Country:** United States

**State:** Florida

**Location 2:**

**City:** Brisbane

**Country:** Australia

**Location 3:**

**City:** Melbourne

**Country:** Australia

**Location 4:**

**City:** Berlin

**Country:** Germany

**Location 5:**

**City:** Hamburg

**Country:** Germany

#### Overall Officials

**Official 1:**

**Affiliation:** Valneva Austria GmbH

**Name:** Andrea Ayad, Dr.

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** Taucher C, Barnett ED, Cramer JP, Eder-Lingelbach S, Jelinek T, Kadlecek V, Kiermayr S, Mills DJ, Pandis D, Reiner D, Dubischar KL. Neutralizing antibody persistence in pediatric travelers from non-JE-endemic countries following vaccination with IXIARO(R) Japanese encephalitis vaccine: An uncontrolled, open-label phase 3 follow-up study. Travel Med Infect Dis. 2020 Mar-Apr;34:101616. doi: 10.1016/j.tmaid.2020.101616. Epub 2020 Mar 7.

**PMID:** 32156630

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000090862

- Term: Neuroinflammatory Diseases

- ID: D000004671

- Term: Encephalitis, Arbovirus

- ID: D000018792

- Term: Encephalitis, Viral

- ID: D000020805

- Term: Central Nervous System Viral Diseases

- ID: D000002494

- Term: Central Nervous System Infections

- ID: D000007239

- Term: Infections

- ID: D000069544

- Term: Infectious Encephalitis

- ID: D000001102

- Term: Arbovirus Infections

- ID: D000079426

- Term: Vector Borne Diseases

- ID: D000096724

- Term: Mosquito-Borne Diseases

- ID: D000014777

- Term: Virus Diseases

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000018177

- Term: Flavivirus Infections

- ID: D000018178

- Term: Flaviviridae Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7825

- Name: Encephalitis

- Relevance: HIGH

- As Found: Encephalitis

- ID: M7835

- Name: Encephalitis, Japanese

- Relevance: HIGH

- As Found: Japanese Encephalitis

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2803

- Name: Neuroinflammatory Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20851

- Name: Encephalitis, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22560

- Name: Central Nervous System Viral Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5743

- Name: Central Nervous System Infections

- Relevance: LOW

- As Found: Unknown

- ID: M457

- Name: Infectious Encephalitis

- Relevance: LOW

- As Found: Unknown

- ID: M4412

- Name: Arbovirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2054

- Name: Vector Borne Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3255

- Name: Mosquito-Borne Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M20323

- Name: Flavivirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M20324

- Name: Flaviviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: T3141

- Name: Japanese Encephalitis

- Relevance: HIGH

- As Found: Japanese Encephalitis

### Condition Browse Module - Meshes

- ID: D000004672

- Term: Encephalitis, Japanese

- ID: D000004660

- Term: Encephalitis

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

#### Removed Countries

- Country: Denmark

- Country: Sweden

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** No Treatment

**Description:** subjects will be followed up on immunity (analysis of blood samples) and safety

Blood draw: blood draw at Month 12, Month 24 and Month 36.

IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.

**ID:** EG000

**Other Num Affected:** 8

**Other Num at Risk:** 23

**Serious Number Affected:** 2

**Serious Number At Risk:** 23

**Title:** No Treatment

**Frequency Threshold:** 5

#### Other Events

**Term:** Otitis media acute

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Pharyngitis streptococcal

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Diarrhoea

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Skin papilloma

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

#### Serious Events

**Term:** Staphylococcal infection

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 23

**Num Events:** 1

**Term:** Tonsillitis

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 23

**Num Events:** 1

**Time Frame:** adverse event data were collected up to month 36 (i.e., approximately 3 years after primary immunization in the parent study IC51-322)

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 23

**Units:** Participants

### Group

**ID:** BG000

**Title:** No Treatment

**Description:** subjects will be followed up on immunity (analysis of blood samples) and safety

Blood draw: blood draw at Month 12, Month 24 and Month 36.

IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 4.3

**Value:** 14.3

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 11

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 12

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** GT60
**Restrictive Agreement:** True
### Point of Contact
**Email:** info@valneva.com
**Organization:** Valneva Austria GmbH
**Phone:** +43120620
**Phone Extension:** 0
**Title:** Senior Scientist Clinical Research
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 68.6
- **Spread:** 
- **Upper Limit:** 97.1
- **Value:** 89.5
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 28.7
- **Spread:** 
- **Upper Limit:** 79.8
- **Value:** 47.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 23
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 45.9
- **Spread:** 
- **Upper Limit:** 123.7
- **Value:** 75.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 19
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 34.8
- **Spread:** 
- **Upper Limit:** 106.1
- **Value:** 60.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 23
**Units:** Participants
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 91.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 21
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 89.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 17
**Units:** Participants
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Rate of subjects with PRNT50 titers of ≥ 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322)
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** intention to treat population; assessment of seroprotection \~1 year post primary vaccination series in parent study IC51-322
**Reporting Status:** POSTED
**Time Frame:** Month 12
**Title:** Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Month 12 After the First IC51 Vaccination (in Study IC51-322)
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** subjects will be followed up on immunity (analysis of blood samples) and safety

Blood draw: blood draw at Month 12, Month 24 and Month 36.

IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.
**ID:** OG000
**Title:** No Treatment
#### Outcome Measure 2
**Description:** GMT for JEV neutralizing antibodies measured using the PRNT at Month 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** Intent to Treat Population
**Reporting Status:** POSTED
**Time Frame:** Month 12, 24 and 36
**Title:** GMT for JEV Neutralizing Antibodies Measured Using the PRNT at Month 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322)
**Type:** SECONDARY
**Unit of Measure:** Titer
##### Group
**Description:** subjects will be followed up on immunity (analysis of blood samples) and safety

Blood draw: blood draw at Month 12, Month 24 and Month 36.

IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.
**ID:** OG000
**Title:** No Treatment
#### Outcome Measure 3
**Description:** Rate of subjects with PRNT50 titers of ≥ 1:10 at Months 24 and 36 after the first IC51 vaccination (in study IC51-322)
**Parameter Type:** NUMBER
**Population Description:** Intent to Treat Population
**Reporting Status:** POSTED
**Time Frame:** Month 24, 36
**Title:** Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Months 24 and 36 After the First IC51 Vaccination (in Study IC51-322)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** subjects will be followed up on immunity (analysis of blood samples) and safety

Blood draw: blood draw at Month 12, Month 24 and Month 36.

IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.
**ID:** OG000
**Title:** No Treatment
#### Outcome Measure 4
**Description:** Rate of subjects with SAEs following immunization up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population
**Reporting Status:** POSTED
**Time Frame:** Months 12, 24 and 36
**Title:** Rate of Subjects With SAEs Following Immunization up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322)
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** subjects will be followed up on immunity (analysis of blood samples) and safety

Blood draw: blood draw at Month 12, Month 24 and Month 36.

IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.
**ID:** OG000
**Title:** No Treatment
#### Outcome Measure 5
**Description:** Rate of subjects with AEs and medically attended AEs up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322).
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety Population
**Reporting Status:** POSTED
**Time Frame:** Months 12, 24 and 36
**Title:** Rate of Subjects With AEs and Medically Attended AEs up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322).
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** subjects will be followed up on immunity (analysis of blood samples) and safety

Blood draw: blood draw at Month 12, Month 24 and Month 36.

IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.
**ID:** OG000
**Title:** No Treatment
### Participant Flow Module
#### Group
**Description:** subjects will be followed up on immunity (analysis of blood samples) and safety

Blood draw: blood draw at Month 12, Month 24 and Month 36.

IC51 has given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.
**ID:** FG000
**Title:** No Treatment
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 23
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 18
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
**Has Results:** True