Immunogenicity and Safety of the Japanese Encephalitis Va... | NCT01047839

Label	Type	Description	Intervention Names
>=2 months to <3 years	Experimental	IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and 28	Biological: IC51
>=3 to <12 years	Experimental	IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28	Biological: IC51
>=12 to <18 years	Experimental	IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28	Biological: IC51

Name	Type	Description	Arm Group Labels	Other Names
IC51	Biological	0.25 ml, 2 i.m. vaccinations at Day 0 and 28	>=2 months to <3 years

Measure	Description	Time Frame
Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination	Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.	until Day 56

Measure	Description	Time Frame
Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination		up to Month 7
Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination

Eligibility Module

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.
The subject is planning to travel to an area where JE is endemic after completion of the vaccination schedule. Exposure to JE should be avoided until 1 week after the second IC51 dose and subjects should return from travel to JE endemic areas before the Month 7 visit. The planned travel to JE endemic areas should not interfere with the study visits and can take place between Visit 2 + 7 days to Month 7.

Exclusion Criteria:

Clinical manifestation or history of any Flavivirus disease
Vaccination against JE (except within this protocol), Yellow fever, West Nile virus and Dengue at any time prior or during the study
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 1 week before and 1 week after each IC51 vaccination.

Name	Affiliation	Role
Andrea Ayad, Dr.	Valneva Austria GmbH	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Tampa Clinical Research Inc.		Tampa	Florida	33624	United States
Passport Health

ID	Title	Description
FG000	>=2 Months to <3 Years	IC51 0.25 ml, 2 intramuscular vaccinations at Day 0 and Day 28
FG001	>=3 to <12 Years	IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28

ID	Title	Description
BG000	>=2 Months to <3 Years	IC51 0.25 ml, 2 i.m.vaccinations at Day 0 and Day 28
BG001	>=3 to <12 Years	IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
BG002	>=12 to <18 Years	IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00012 BG00129 BG00259 BG003100

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination

Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.

Posted

Number

95% Confidence Interval

percentage of participants

until Day 56

ID	Title	Description
OG000	>=2 Months to <3 Years	IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
OG001	>=3 to <12 Years	IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
OG002	>=12 to <18 Years	IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28

Units	Counts
Participants	OG00012 OG00129 OG00259

Title

Denominators

Categories

Title	Measurements
	OG00033.3(9.9 to 65.1) OG00120.7(8.0 to 39.7) OG0023.4(0.4 to 11.7)

Secondary

Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination

Posted

Number

95% Confidence Interval

percentage of participants

up to Month 7

ID	Title	Description
OG000	IC51 0.25 mL	0.25 mL i.m. vaccinations on Day 0 and Day 28 subjects aged >= 2 months to < 3years
OG001	IC51 0.5 mL	0.5 mL i.m. vaccinations on Day 0 and Day 28 subjects >= 3 years to < 18 years

Units	Counts
Participants	OG000

Secondary

Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination

Posted

Number

95% Confidence Interval

percentage of participants

7 days

ID	Title	Description
OG000	IC51 0.25 mL	0.25 mL i.m. vaccinations on Day 0 and Day 28 subjects aged >= 2 months to < 3years
OG001	IC51 0.5 mL	0.5 mL i.m. vaccinations on Day 0 and Day 28 subjects >= 3 years to < 18 years

Units	Counts
Participants	OG000

Secondary

Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination

Posted

Number

95% Confidence Interval

percentage of participants

up to Day 56 and upt to Month 7

ID	Title	Description
OG000	IC51 0.25 mL	0.25 mL i.m. vaccinations on Day 0 and Day 28 subjects aged >= 2 months to < 3years
OG001	IC51 0.5 mL	0.5 mL i.m. vaccinations on Day 0 and Day 28 subjects >= 3 years to < 18 years

Units	Counts
Participants	OG000

Secondary

Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination

Laboratory parameters were assessed at the Day 28, Day 56 and Month 7 visit. Endpoint reflects abnormal laboratory parameters assessed as clinically significant by the investigator.

not from all subjects samples were collected, Overall number of participants analyzed were number of participants at Day 0

Posted

Count of Participants

Participants

up to Month 7

ID	Title	Description
OG000	IC51 0.25 mL	0.25 mL i.m. vaccinations on Day 0 and Day 28 subjects aged >= 2 months to < 3years
OG001	IC51 0.5 mL	0.5 mL i.m. vaccinations on Day 0 and Day 28 subjects >= 3 years to < 18 years

Units	Counts
Participants	OG000

Secondary

SCRs as Defined as Percentage of Subjects With JEV Neutralizing Antibody Titers of PRNT 50 >= 1:10 at Day 56 and Month 7, Measured Using a Validated Plaque Reduction Neutralization Test (PRNT)

number analyzed = number of subjects achieving seroconversion Overall number of participants analyzed were number of participants at Day 0

Posted

Number

95% Confidence Interval

percentage of participants

at Day 56 and Month 7

ID	Title	Description
OG000	IC51 0.25 mL	0.25 mL i.m. vaccinations on Day 0 and Day 28 subjects aged >= 2 months to < 3years
OG001	IC51 0.5 mL	0.5 mL i.m. vaccinations on Day 0 and Day 28 subjects >= 3 years to < 18 years

Units	Counts
Participants	OG000

Secondary

GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7

Posted

Geometric Mean

95% Confidence Interval

Titer

at Day 56 and Month 7

ID	Title	Description
OG000	IC51 0.25 mL	0.25 mL i.m. vaccinations on Day 0 and Day 28 subjects aged >= 2 months to < 3years
OG001	IC51 0.5 mL	0.5 mL i.m. vaccinations on Day 0 and Day 28 subjects >= 3 years to < 18 years

Units	Counts
Participants	OG000

Secondary

SCRs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups

number analyzed = number of subjects achieving seroconversion Overall number of participants analyzed were number of participants at Day 0

Posted

Number

95% Confidence Interval

percentage of participants

at Day 56 and Month 7

ID	Title	Description
OG000	>=2 Months to <3 Years	IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and 28 IC51: 0.25 ml, 2 i.m. vaccinations at Day 0 and 28
OG001	>=3 to <12 Years	IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28 IC51: 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
OG002	>=12 to <18 Years	IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28 IC51: 0.5 ml, 2 i.m. vaccinations at Day 0 and 28

Units	Counts
Participants

Secondary

GMTs at Day 56 and Month 7 Stratified According to Age Groups

Posted

Mean

95% Confidence Interval

Titer

at Day 56 and Month 7

ID	Title	Description
OG000	>=2 Months to <3 Years	IC51 0.25 ml, 2 intramuscular vaccinations at Day 0 and Day 28
OG001	>=3 to <12 Years	IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
OG002	>=12 to <18 Years	IC51, 0.5 ml, 2 intramuscular vaccinations at Day 0 and 28

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Nasopharyngitis	Infections and infestations			EG0004 events4 affected12 at risk EG0014 events4 affected29 at risk EG0020 events0 affected59 at risk
Bronchitis	Infections and infestations			EG0001 events1 affected12 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk
Upper Respiratory Tract Infection	Infections and infestations			EG0002 events1 affected12 at risk EG0013 events2 affected29 at risk EG0020 events0 affected59 at risk
Abdominal Pain Upper	Gastrointestinal disorders			EG0001 events1 affected12 at risk EG0010 events0 affected29 at risk EG0023 events3 affected59 at risk
Diarrhoea	Gastrointestinal disorders			EG0001 events1 affected12 at risk EG0010 events0 affected29 at risk EG0022 events2 affected59 at risk
Haematochezia	Gastrointestinal disorders			EG0001 events1 affected12 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk
Nausea	Gastrointestinal disorders			EG0002 events1 affected12 at risk EG0010 events0 affected29 at risk EG0023 events2 affected59 at risk
Vomiting	Gastrointestinal disorders			EG0001 events1 affected12 at risk EG0012 events2 affected29 at risk EG0023 events3 affected59 at risk
Pyrexia	General disorders			EG0005 events3 affected12 at risk EG0013 events2 affected29 at risk EG0021 events1 affected59 at risk
Influenza like Illness	General disorders			EG0001 events1 affected12 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk
Cough	Respiratory, thoracic and mediastinal disorders			EG0002 events2 affected12 at risk EG0013 events3 affected29 at risk EG0021 events1 affected59 at risk
Pharyngeal Erythema	Respiratory, thoracic and mediastinal disorders			EG0001 events1 affected12 at risk EG0012 events2 affected29 at risk EG0021 events1 affected59 at risk
Lymphadenopathy	Blood and lymphatic system disorders			EG0002 events2 affected12 at risk EG0014 events3 affected29 at risk EG0020 events0 affected59 at risk
Ear Canal Erythema	Ear and labyrinth disorders			EG0001 events1 affected12 at risk EG0011 events1 affected29 at risk EG0020 events0 affected59 at risk
Excoriation	Injury, poisoning and procedural complications			EG0001 events1 affected12 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk
White Blood Cell Count Decreased	Investigations			EG0001 events1 affected12 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk
Initial Insomnia	Psychiatric disorders			EG0001 events1 affected12 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk
Pruritus	Skin and subcutaneous tissue disorders			EG0001 events1 affected12 at risk EG0012 events1 affected29 at risk EG0020 events0 affected59 at risk
Rash Erythematous	Skin and subcutaneous tissue disorders			EG0001 events1 affected12 at risk EG0010 events0 affected29 at risk EG0020 events0 affected59 at risk
Asthma	Respiratory, thoracic and mediastinal disorders			EG0000 events0 affected12 at risk EG0013 events2 affected29 at risk EG0020 events0 affected59 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders			EG0000 events0 affected12 at risk EG0012 events2 affected29 at risk EG0020 events0 affected59 at risk
Headache	Nervous system disorders			EG0000 events0 affected12 at risk EG0011 events1 affected29 at risk EG0023 events3 affected59 at risk
Orapharyngeal Pain	Respiratory, thoracic and mediastinal disorders			EG0000 events0 affected12 at risk EG0011 events1 affected29 at risk EG0023 events3 affected59 at risk
Injection Site Pain	General disorders	Systematic Assessment	solicited local	EG0000 events0 affected12 at risk EG0013 events3 affected29 at risk EG00225 events19 affected59 at risk
Injection Site Itching	General disorders	Systematic Assessment	solicited local	EG0000 events0 affected12 at risk EG0011 events1 affected29 at risk EG0023 events3 affected59 at risk
Tenderness	General disorders	Systematic Assessment	solicited local	EG0001 events1 affected12 at risk EG00119 events13 affected29 at risk EG00242 events31 affected59 at risk
Hardening	General disorders	Systematic Assessment	solicited local	EG0002 events1 affected12 at risk EG0010 events0 affected29 at risk EG0024 events4 affected59 at risk
Redness	General disorders	Systematic Assessment	solicited local	EG0003 events3 affected12 at risk EG0012 events2 affected29 at risk EG0022 events2 affected59 at risk
Irritability	General disorders	Systematic Assessment	solicited systemic	EG0000 events0 affected12 at risk EG0017 events5 affected29 at risk EG0021 events1 affected59 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	solicited systemic	EG0000 events0 affected12 at risk EG0012 events2 affected29 at risk EG0027 events3 affected59 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	solicited systemic	EG0003 events2 affected12 at risk EG0011 events1 affected29 at risk EG0022 events2 affected59 at risk
Excessive Fatigue	General disorders	Systematic Assessment	solicited systemic	EG0000 events0 affected12 at risk EG0013 events3 affected29 at risk EG0027 events7 affected59 at risk
Muscle Pain	General disorders	Systematic Assessment	solicited systemic	EG0000 events0 affected12 at risk EG0015 events4 affected29 at risk EG00229 events23 affected59 at risk
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	solicited systemic	EG0000 events0 affected12 at risk EG0014 events3 affected29 at risk EG0021 events1 affected59 at risk
Headache	Nervous system disorders	Systematic Assessment	solicited systemic	EG0000 events0 affected12 at risk EG0015 events3 affected29 at risk EG0028 events4 affected59 at risk
Loss of appetite	General disorders	Systematic Assessment	solicited systemic	EG0001 events1 affected12 at risk EG0011 events1 affected29 at risk EG0020 events0 affected59 at risk
Fever	General disorders	Systematic Assessment	solicited systemic	EG0000 events0 affected12 at risk EG0011 events1 affected29 at risk EG0023 events3 affected59 at risk

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D000090862	Neuroinflammatory Diseases

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	>=2 Months to <3 Years	IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28	0	12	11	12
EG001	>=3 to <12 Years	IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28	0	29	22	29
EG002	>=12 to <18 Years	IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28	3	59	49	59

Term	Organ System	Statistical Information
Type 1 diabetes mellitus	Metabolism and nutrition disorders	EG0000 events0 affected12 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk
Dizziness	Nervous system disorders	EG0000 events0 affected12 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk
Intentional self-injury	Psychiatric disorders	EG0000 events0 affected12 at risk EG0010 events0 affected29 at risk EG0021 events1 affected59 at risk