Trial Outcomes & Findings for Safety and Tolerability of the Japanese Encephalitis Vaccine IC51 (NCT NCT00605085)

NCT ID: NCT00605085

Last Updated: 2024-03-21

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2675 participants

Primary outcome timeframe

Day 56

Results posted on

2024-03-21

Participant Flow

Participant milestones

Participant milestones
Measure	IC51 IC51	Placebo Placebo
Overall Study STARTED	2012	663
Overall Study COMPLETED	1962	638
Overall Study NOT COMPLETED	50	25

Reasons for withdrawal

Reasons for withdrawal
Measure	IC51 IC51	Placebo Placebo
Overall Study Withdrawal by Subject	8	5
Overall Study Adverse Event	9	5
Overall Study Pregnancy	2	0
Overall Study Protocol Violation	3	2
Overall Study Lost to Follow-up	10	5
Overall Study administrative reasons	18	8

Baseline Characteristics

Safety and Tolerability of the Japanese Encephalitis Vaccine IC51

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IC51 n=1993 Participants IC51	Placebo n=657 Participants Placebo	Total n=2650 Participants Total of all reporting groups
Age, Continuous	33.9 years STANDARD_DEVIATION 13.3 • n=93 Participants	33.4 years STANDARD_DEVIATION 13 • n=4 Participants	33.8 years STANDARD_DEVIATION 13.2 • n=27 Participants
Sex: Female, Male Female	1088 Participants n=93 Participants	378 Participants n=4 Participants	1466 Participants n=27 Participants
Sex: Female, Male Male	905 Participants n=93 Participants	279 Participants n=4 Participants	1184 Participants n=27 Participants
Region of Enrollment Australia	294 participants n=93 Participants	100 participants n=4 Participants	394 participants n=27 Participants
Region of Enrollment Europe	1236 participants n=93 Participants	406 participants n=4 Participants	1642 participants n=27 Participants
Region of Enrollment United States	463 participants n=93 Participants	151 participants n=4 Participants	614 participants n=27 Participants

PRIMARY outcome

Timeframe: Day 56

Population: Safety Population

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

Outcome measures

Outcome measures
Measure	IC51 n=1993 Participants IC51	Placebo n=657 Participants Placebo
Safety and Tolerability up to Day 56	58.9 percentage of participants with AEs	56.6 percentage of participants with AEs

SECONDARY outcome

Timeframe: until Day 56

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: until Day 56

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: until Day 56

Outcome measures

Outcome data not reported

Adverse Events

IC51

Serious events: 10 serious events

Other events: 917 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 292 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	IC51 n=1993 participants at risk IC51	Placebo n=657 participants at risk Placebo
Gastrointestinal disorders Nausea	6.6% 131/1993 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.	7.5% 49/657 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.
General disorders Fatigue	11.4% 227/1993 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.	11.7% 77/657 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.
General disorders Influenza Like Illness	12.4% 248/1993 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.	11.9% 78/657 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.
General disorders Pyrexia	3.2% 64/1993 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.	3.0% 20/657 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.
Infections and infestations Nasopharyngitis	4.7% 94/1993 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.	4.0% 26/657 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.
Musculoskeletal and connective tissue disorders Myalgia	15.6% 311/1993 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.	15.5% 102/657 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.
Nervous system disorders Headache	28.0% 559/1993 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.	26.3% 173/657 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.

Additional Information

Senior Manager Clinical Research

Intercell AG

Phone: +43 1 206 20

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	IC51 n=1993 participants at risk IC51	Placebo n=657 participants at risk Placebo
Cardiac disorders Acute Coronary Syndrome	0.00% 0/1993 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.	0.15% 1/657 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.
Gastrointestinal disorders Proctalgia	0.00% 0/1993 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.	0.15% 1/657 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.
Gastrointestinal disorders Rectal Haemorrhage	0.05% 1/1993 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.	0.00% 0/657 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.
General disorders Chest Pain	0.05% 1/1993 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.	0.00% 0/657 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.
Infections and infestations Abscess Limb	0.05% 1/1993 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.	0.00% 0/657 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.
Infections and infestations Appendicitis	0.05% 1/1993 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.	0.30% 2/657 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.
Injury, poisoning and procedural complications Face Injury	0.05% 1/1993 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.	0.00% 0/657 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.
Injury, poisoning and procedural complications Facial Bones Fracture	0.05% 1/1993 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.	0.00% 0/657 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.
Injury, poisoning and procedural complications Ulna Fracture	0.05% 1/1993 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.	0.00% 0/657 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.
Renal and urinary disorders Calculus Urinary	0.00% 0/1993 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.	0.15% 1/657 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.
Reproductive system and breast disorders Adnexa Uteri Pain	0.05% 1/1993 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.	0.00% 0/657 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.
Reproductive system and breast disorders Ovarian Cyst Ruptured	0.05% 1/1993 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.	0.00% 0/657 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.
Reproductive system and breast disorders Ovarian Torsion	0.05% 1/1993 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.	0.00% 0/657 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.
Skin and subcutaneous tissue disorders Dermatomyositis	0.05% 1/1993 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.	0.00% 0/657 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.
Vascular disorders Curculatory Collapse	0.00% 0/1993 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.	0.15% 1/657 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.