Safety and Tolerability of the Japanese Encephalitis Vaccine IC51

• Sponsor: Valneva Austria GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00605085
• Collaborator: (none)
• Enrollment: 2,675
• Arms: 2
• Duration (Months): 13

Study Details

Study Description

Brief Summary

The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control in healthy subjects aged > or = 18 years

Condition or Disease	Intervention/Treatment	Phase
Japanese Encephalitis	Biological: Japanese Encephalitis purified inactivated vaccine (IC51); Biological: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 2675 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Safety and Tolerability of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Placebo Controlled Phase 3 Study
• Study Start Date: Oct 1, 2005
• Actual Study Completion Date: Nov 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 IC51	Biological: Japanese Encephalitis purified inactivated vaccine (IC51); IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
Placebo Comparator: 2 Placebo	Biological: Placebo; Placebo: Phosphate-buffered saline (PBS) solution containing 0.1% aluminum hydroxide as an adjuvant, 0.5 mL, i.m. injection, 2 injections, days 0 and 28

Outcome Measures

Primary Outcome Measures

1. Safety and Tolerability up to Day 56 [Day 56]

   calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)

Secondary Outcome Measures

1. Rates of Serious Adverse Events and Medically Attended Adverse Events [until Day 56]

2. Changes in Laboratory Parameters [until Day 56]

3. SCR and GMT of Subjects With Concomitant Vaccinations [until Day 56]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• At least 18 years of age

• Written informed consent obtained prior to study entry

Exclusion Criteria:

• Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine

• History of any previous JE vaccination (e.g. JE-VAX®)

• Immunodeficiency including post-organ-transplantation or immunosuppressive therapy

• A family history of congenital or hereditary immunodeficiency

• History of autoimmune disease

• Any acute infections within 2 weeks prior to enrollment

• Known or suspected HIV Infection

• Pregnancy, lactation or unreliable contraception in female subjects

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Valneva Austria GmbH

Investigators

• Study Director: Astrid Kaltenboeck, Ph.D., Valneva Austria GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00605085
• Other Study ID Numbers: IC51-302
• First Posted: Jan 30, 2008
• Last Update Posted: Nov 20, 2012
• Last Verified: Oct 1, 2012

• Additional relevant MeSH terms: Encephalitis, Japanese; Encephalitis

Study Results

Participant Flow

Arm/Group Title	IC51	Placebo
Arm/Group Description	IC51	Placebo
Period Title: Overall Study
STARTED	2012	663
COMPLETED	1962	638
NOT COMPLETED	50	25

Baseline Characteristics

Arm/Group Title	IC51	Placebo	Total
Arm/Group Description	IC51	Placebo	Total of all reporting groups
Overall Participants	1993	657	2650
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.9 (13.3)	33.4 (13)	33.8 (13.2)
Sex: Female, Male (Count of Participants)
Female	1088 54.6%	378 57.5%	1466 55.3%
Male	905 45.4%	279 42.5%	1184 44.7%
Region of Enrollment (participants) [Number]
Australia	294 14.8%	100 15.2%	394 14.9%
Europe	1236 62%	406 61.8%	1642 62%
United States	463 23.2%	151 23%	614 23.2%

Outcome Measures

1. Primary Outcome

Title	Safety and Tolerability up to Day 56
Description	calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)
Time Frame	Day 56

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	IC51	Placebo
Arm/Group Description	IC51	Placebo
Measure Participants	1993	657
Number [percentage of participants with AEs]	58.9 3%	56.6 8.6%

2. Secondary Outcome

Title	Rates of Serious Adverse Events and Medically Attended Adverse Events
Time Frame	until Day 56

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Changes in Laboratory Parameters
Time Frame	until Day 56

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	SCR and GMT of Subjects With Concomitant Vaccinations
Time Frame	until Day 56

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Adverse Event Reporting Description	Safet population (N = 2650): All subjects who entered the study and received at least one vaccination. All analyses based on the safety population were carried out using the actual treatment received. The safety population was used for all safety and tolerability analyses and for the analysis of demographic and background data.
Arm/Group Title	IC51		Placebo
Arm/Group Description	IC51		Placebo
All Cause Mortality
	IC51		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	IC51		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/1993 (0.5%)		6/657 (0.9%)
Cardiac disorders
Acute Coronary Syndrome	0/1993 (0%)		1/657 (0.2%)
Gastrointestinal disorders
Proctalgia	0/1993 (0%)		1/657 (0.2%)
Rectal Haemorrhage	1/1993 (0.1%)		0/657 (0%)
General disorders
Chest Pain	1/1993 (0.1%)		0/657 (0%)
Infections and infestations
Abscess Limb	1/1993 (0.1%)		0/657 (0%)
Appendicitis	1/1993 (0.1%)		2/657 (0.3%)
Injury, poisoning and procedural complications
Face Injury	1/1993 (0.1%)		0/657 (0%)
Facial Bones Fracture	1/1993 (0.1%)		0/657 (0%)
Ulna Fracture	1/1993 (0.1%)		0/657 (0%)
Renal and urinary disorders
Calculus Urinary	0/1993 (0%)		1/657 (0.2%)
Reproductive system and breast disorders
Adnexa Uteri Pain	1/1993 (0.1%)		0/657 (0%)
Ovarian Cyst Ruptured	1/1993 (0.1%)		0/657 (0%)
Ovarian Torsion	1/1993 (0.1%)		0/657 (0%)
Skin and subcutaneous tissue disorders
Dermatomyositis	1/1993 (0.1%)		0/657 (0%)
Vascular disorders
Curculatory Collapse	0/1993 (0%)		1/657 (0.2%)
Other (Not Including Serious) Adverse Events
	IC51		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	917/1993 (46%)		292/657 (44.4%)
Gastrointestinal disorders
Nausea	131/1993 (6.6%)		49/657 (7.5%)
General disorders
Fatigue	227/1993 (11.4%)		77/657 (11.7%)
Influenza Like Illness	248/1993 (12.4%)		78/657 (11.9%)
Pyrexia	64/1993 (3.2%)		20/657 (3%)
Infections and infestations
Nasopharyngitis	94/1993 (4.7%)		26/657 (4%)
Musculoskeletal and connective tissue disorders
Myalgia	311/1993 (15.6%)		102/657 (15.5%)
Nervous system disorders
Headache	559/1993 (28%)		173/657 (26.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.