Trial Outcomes & Findings for Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51 (NCT NCT00595790)

NCT ID: NCT00595790

Last Updated: 2014-04-29

Results Overview

Seroconversion rate: percentage of subjects with \>= 1:10 anti-JEV neutralizing antibody titer

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 374 participants
• Primary outcome timeframe: day 56
• Results posted on: 2014-04-29

Participant Flow

Participant milestones

Measure	IC51 2 x 6 mcg 2 x 6 mcg (microgram)	IC51 1 x 12 mcg 1 x 12 mcg (microgram)	IC51 1 x 6 mcg 1 x 6 mcg (microgram)
Overall Study STARTED	125	124	125
Overall Study COMPLETED	123	123	122
Overall Study NOT COMPLETED	2	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51

Baseline characteristics by cohort

Measure	IC51 2 x 6 mcg n=125 Participants 2 x 6 mcg (microgram)	IC51 1 x 12 mcg n=125 Participants 1 x 12 mcg (microgram)	IC51 1 x 6 mcg n=124 Participants 1 x 6 mcg (microgram)	Total n=374 Participants Total of all reporting groups
Age, Continuous	39.6 years STANDARD_DEVIATION 14.2 • n=5 Participants	41.2 years STANDARD_DEVIATION 15.0 • n=7 Participants	41.6 years STANDARD_DEVIATION 14.8 • n=5 Participants	40.8 years STANDARD_DEVIATION 14.7 • n=4 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	65 Participants n=7 Participants	61 Participants n=5 Participants	197 Participants n=4 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	60 Participants n=7 Participants	63 Participants n=5 Participants	177 Participants n=4 Participants
Region of Enrollment United Kingdom	58 participants n=5 Participants	58 participants n=7 Participants	57 participants n=5 Participants	173 participants n=4 Participants
Region of Enrollment Germany	67 participants n=5 Participants	67 participants n=7 Participants	67 participants n=5 Participants	201 participants n=4 Participants

PRIMARY outcome

Timeframe: day 56

Population: The Participant Flow shows all study participants randomized. The Primary Outcome is based on the Per-Protocol-Population (all randomized subjects without major protocol deviation

Seroconversion rate: percentage of subjects with >= 1:10 anti-JEV neutralizing antibody titer

Outcome measures

Measure	IC51 1 x 12 mcg n=115 Participants	IC51 2x6 mcg n=115 Participants	IC51 1x6 mcg n=119 Participants
SCR (Seroconversion Rate) at Day 56	41.2 percentage of participants Interval 32.2 to 50.3	97.3 percentage of participants Interval 94.4 to 100.0	25.6 percentage of participants Interval 17.7 to 33.6

SECONDARY outcome

Timeframe: Day 10, 28 and 35

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 10, 28, 35 and 56

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Study duration

AEs, Local and systemic tolerability, Safety laboratory parameters

Outcome measures

Outcome data not reported

Adverse Events

IC51 2 x 6 mcg

Serious events: 0 serious events

Other events: 78 other events

Deaths: 0 deaths

IC51 1 x 12 mcg

Serious events: 1 serious events

Other events: 82 other events

Deaths: 0 deaths

IC51 1 x 6 mcg

Serious events: 0 serious events

Other events: 78 other events

Deaths: 0 deaths

Serious adverse events

Measure	IC51 2 x 6 mcg n=125 participants at risk 2 x 6 mcg (microgram)	IC51 1 x 12 mcg n=125 participants at risk 1 x 12 mcg (microgram)	IC51 1 x 6 mcg n=124 participants at risk 1 x 6 mcg (microgram)
General disorders Chest pain	0.00% 0/125	0.80% 1/125 • Number of events 1	0.00% 0/124

Other adverse events

Measure	IC51 2 x 6 mcg n=125 participants at risk 2 x 6 mcg (microgram)	IC51 1 x 12 mcg n=125 participants at risk 1 x 12 mcg (microgram)	IC51 1 x 6 mcg n=124 participants at risk 1 x 6 mcg (microgram)
Musculoskeletal and connective tissue disorders Myalgia	20.0% 25/125 • Number of events 26	29.6% 37/125 • Number of events 41	29.0% 36/124 • Number of events 40
General disorders Influenza like illness	16.8% 21/125 • Number of events 22	21.6% 27/125 • Number of events 31	17.7% 22/124 • Number of events 26
General disorders Fatique	7.2% 9/125 • Number of events 12	14.4% 18/125 • Number of events 21	8.9% 11/124 • Number of events 11
Nervous system disorders Headache	24.0% 30/125 • Number of events 40	27.2% 34/125 • Number of events 49	27.4% 34/124 • Number of events 51
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	6.4% 8/125 • Number of events 8	4.8% 6/125 • Number of events 6	4.8% 6/124 • Number of events 6

Additional Information

Senior Manager Clinical Research

Intercell AG

Phone: +43 1 206 20

Email: kdubischar-kastner@intercell.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER