Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

• Sponsor: Valneva Austria GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00594958
• Collaborator: (none)
• Enrollment: 639
• Arms: 3
• Duration (Months): 12

Study Details

Study Description

Brief Summary

The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean Titers for anti-JEV neutralizing antibody.

Condition or Disease	Intervention/Treatment	Phase
Japanese Encephalitis	Biological: IC51	Phase 3

Detailed Description

This is a randomized, controlled, multi-center, double blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years.

624 subjects will be enrolled at approximately 6 sites in study centers in Austria and Germany.

Study Design

• Study Type: Interventional
• Actual Enrollment: 639 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Apr 1, 2007
• Actual Study Completion Date: Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: IC51 Group A IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches	Biological: IC51; 6 mcg, intramuscularly [i.m.], 0.5 mL; Other Names: Japanese Encephalitis purified inactivated vaccine
Active Comparator: IC51 Group B IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches	Biological: IC51; 6 mcg, intramuscularly [i.m.], 0.5 mL; Other Names: Japanese Encephalitis purified inactivated vaccine
Active Comparator: IC51 Group C IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches	Biological: IC51; 6 mcg, intramuscularly [i.m.], 0.5 mL; Other Names: Japanese Encephalitis purified inactivated vaccine

Outcome Measures

Primary Outcome Measures

1. GMT for Anti-JEV Neutralizing Antibody [day 56]

   Equivalence between batches with regards to GMT (Geometric Mean Titer) was postulated if all three pair-wise 95 % Confidence Intervals for GMT ratios were between 0.5 and 2.

Secondary Outcome Measures

1. Safety [study duration]

   Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability

2. SCR for Anti-JEC Neutralizing Antibody Titer [day 56]

Eligibility Criteria

Criteria

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

Main Inclusion Criteria:

• Male and female subjects aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test

Main Exclusion Criteria:

• History of immunodeficiency or immunosuppressive therapy, known HIV, drug addiction including alcohol dependence

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Valneva Austria GmbH

Investigators

• Study Director: Susanne Eder, Mag., Valneva Austria GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Valneva Austria GmbH
• ClinicalTrials.gov Identifier: NCT00594958
• Other Study ID Numbers: IC51-309
• First Posted: Jan 16, 2008
• Last Update Posted: May 4, 2016
• Last Verified: Mar 1, 2016

• Additional relevant MeSH terms: Encephalitis, Japanese; Encephalitis; Vaccines

Study Results

Participant Flow

Arm/Group Title	IC51 Group A	IC51 Group B	IC51 Group C
Arm/Group Description	IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches	IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches	IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
Period Title: Overall Study
STARTED	214	213	212
Randomized and at Least 1 Vaccination	212	213	211
COMPLETED	200	210	202
NOT COMPLETED	14	3	10

Baseline Characteristics

Arm/Group Title	IC51 Group A	IC51 Group B	IC51 Group C	Total
Arm/Group Description	IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches	IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches	IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches	Total of all reporting groups
Overall Participants	212	213	211	636
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.7 (10.8)	31.3 (11.0)	30.7 (10.3)	31.3 (10.7)
Sex: Female, Male (Count of Participants)
Female	108 50.9%	123 57.7%	119 56.4%	350 55%
Male	104 49.1%	90 42.3%	92 43.6%	286 45%
Region of Enrollment (participants) [Number]
Europe	212 100%	213 100%	211 100%	636 100%

Outcome Measures

1. Primary Outcome

Title	GMT for Anti-JEV Neutralizing Antibody
Description	Equivalence between batches with regards to GMT (Geometric Mean Titer) was postulated if all three pair-wise 95 % Confidence Intervals for GMT ratios were between 0.5 and 2.
Time Frame	day 56

Outcome Measure Data

Analysis Population Description

Per Protocol Population (observed values)

Arm/Group Title	IC51 Group A	IC51 Group B	IC51 Group C
Arm/Group Description	IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches	IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches	IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
Measure Participants	197	202	200
Geometric Mean (95% Confidence Interval) [GMT]	160.71	272.24	127.56

2. Secondary Outcome

Title	Safety
Description	Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability
Time Frame	study duration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	SCR for Anti-JEC Neutralizing Antibody Titer
Time Frame	day 56

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	up to Month 6
Arm/Group Title	IC51 Group A		IC51 Group B		IC51 Group C
Arm/Group Description	IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches		IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches		IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
All Cause Mortality
	IC51 Group A		IC51 Group B		IC51 Group C
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	IC51 Group A		IC51 Group B		IC51 Group C
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/212 (1.4%)		2/213 (0.9%)		5/211 (2.4%)
Gastrointestinal disorders
Reflux Oesophagitis	1/212 (0.5%)		0/213 (0%)		0/211 (0%)
Acute Abdomen	0/212 (0%)		0/213 (0%)		1/211 (0.5%)
Hepatobiliary disorders
Cholecystitis Acute	0/212 (0%)		0/213 (0%)		1/211 (0.5%)
Infections and infestations
Erysipelas	0/212 (0%)		1/213 (0.5%)		0/211 (0%)
Herpes Zoster	0/212 (0%)		0/213 (0%)		1/211 (0.5%)
Peritonsillar Abscess	0/212 (0%)		1/213 (0.5%)		0/211 (0%)
Respiratory Tract Infection	1/212 (0.5%)		0/213 (0%)		0/211 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer	0/212 (0%)		0/213 (0%)		1/211 (0.5%)
Nervous system disorders
Intracranial Aneurysm	1/212 (0.5%)		0/213 (0%)		0/211 (0%)
Renal and urinary disorders
Renal Colic	0/212 (0%)		0/213 (0%)		1/211 (0.5%)
Other (Not Including Serious) Adverse Events
	IC51 Group A		IC51 Group B		IC51 Group C
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	102/212 (48.1%)		124/213 (58.2%)		114/211 (54%)
Gastrointestinal disorders
Nausea	10/212 (4.7%)		21/213 (9.9%)		15/211 (7.1%)
Diarrhoea	2/212 (0.9%)		5/213 (2.3%)		4/211 (1.9%)
General disorders
Fatigue	21/212 (9.9%)		30/213 (14.1%)		34/211 (16.1%)
Influenza Like Ilness	24/212 (11.3%)		35/213 (16.4%)		32/211 (15.2%)
Infections and infestations
Nasopharyngitis	28/212 (13.2%)		34/213 (16%)		30/211 (14.2%)
Rhinitis	12/212 (5.7%)		12/213 (5.6%)		10/211 (4.7%)
Acute Tonsillitis	5/212 (2.4%)		0/213 (0%)		0/211 (0%)
Gastroenteritis	1/212 (0.5%)		7/213 (3.3%)		2/211 (0.9%)
Musculoskeletal and connective tissue disorders
Myalgia	14/212 (6.6%)		21/213 (9.9%)		18/211 (8.5%)
Back Pain	4/212 (1.9%)		5/213 (2.3%)		1/211 (0.5%)
Nervous system disorders
Headache	42/212 (19.8%)		51/213 (23.9%)		52/211 (24.6%)
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain	5/212 (2.4%)		6/213 (2.8%)		3/211 (1.4%)
Skin and subcutaneous tissue disorders
Rash	4/212 (1.9%)		5/213 (2.3%)		1/211 (0.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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