Trial Outcomes & Findings for Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440 (NCT NCT00596271)
NCT ID: NCT00596271
Last Updated: 2014-05-13
Results Overview
anti-JEV Neutralizing Antibodies were tabulated for IC51 groups only; for HAV GMTs (co-primary endpoint GMT for Hepatitis A Virus (HAV) Antibody at Day 28), please refer to "Outcome 2" within outcome measure section
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
192 participants
Primary outcome timeframe
Day 56
Results posted on
2014-05-13
Participant Flow
First Subject In: 26.09.2005, Last Subject Out: 14.07.2006 performed at centers for travelling medicine/vaccinology
Participant milestones
| Measure |
IC51 and Placebo
6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
|
HAVRIX and Placebo
HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
|
IC51 and HAVRIX
IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
|
|---|---|---|---|
|
Overall Study
STARTED
|
65
|
65
|
62
|
|
Overall Study
COMPLETED
|
60
|
59
|
61
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440
Baseline characteristics by cohort
| Measure |
IC51 and Placebo
n=65 Participants
6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
|
HAVRIX and Placebo
n=65 Participants
HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
|
IC51 and HAVRIX
n=62 Participants
IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
65 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
192 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Region of Enrollment
Europe
|
65 participants
n=5 Participants
|
65 participants
n=7 Participants
|
62 participants
n=5 Participants
|
192 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 56Population: Per Protocol Population includes all randomized subjects without major protocol deviations
anti-JEV Neutralizing Antibodies were tabulated for IC51 groups only; for HAV GMTs (co-primary endpoint GMT for Hepatitis A Virus (HAV) Antibody at Day 28), please refer to "Outcome 2" within outcome measure section
Outcome measures
| Measure |
IC51 and Placebo
n=58 Participants
|
IC51 and HAVRIX
n=58 Participants
|
|---|---|---|
|
Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies
|
192.2 titers
Interval 147.9 to 249.8
|
202.7 titers
Interval 153.7 to 261.2
|
PRIMARY outcome
Timeframe: Day 28Outcome measures
| Measure |
IC51 and Placebo
n=52 Participants
|
IC51 and HAVRIX
n=58 Participants
|
|---|---|---|
|
GMT for Hepatitis A Virus (HAV) Antibody at Day 28
|
21.7 titers
Interval 17.2 to 27.5
|
24 titers
Interval 19.1 to 30.1
|
SECONDARY outcome
Timeframe: day 28 and 56Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: day 28 and 56Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: until 6 month after last vaccinationRate of Adverse Events (AEs), Serious Adverse Events (SAEs) and medically attended AEs, local and systemic tolerability, changes in safety laboratory parameters (hematology, serum chemistry, urinalysis)
Outcome measures
Outcome data not reported
Adverse Events
IC51 and Placebo
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
HAVRIX and Placebo
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
IC51 and HAVRIX
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IC51 and Placebo
n=65 participants at risk
6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
|
HAVRIX and Placebo
n=65 participants at risk
HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
|
IC51 and HAVRIX
n=62 participants at risk
IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
|
|---|---|---|---|
|
Nervous system disorders
Convulsion
|
1.5%
1/65 • Number of events 1
|
0.00%
0/65
|
0.00%
0/62
|
Other adverse events
| Measure |
IC51 and Placebo
n=65 participants at risk
6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
|
HAVRIX and Placebo
n=65 participants at risk
HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
|
IC51 and HAVRIX
n=62 participants at risk
IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
1.5%
1/65
|
1.5%
1/65
|
3.2%
2/62
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/65
|
1.5%
1/65
|
3.2%
2/62
|
|
General disorders
Fatique
|
3.1%
2/65
|
7.7%
5/65
|
8.1%
5/62
|
|
General disorders
Influenza like illness
|
9.2%
6/65
|
4.6%
3/65
|
4.8%
3/62
|
|
General disorders
Pyrexia
|
3.1%
2/65
|
0.00%
0/65
|
3.2%
2/62
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
4/65
|
6.2%
4/65
|
8.1%
5/62
|
|
Infections and infestations
Cystitis
|
1.5%
1/65
|
1.5%
1/65
|
3.2%
2/62
|
|
Infections and infestations
Rhinitis
|
3.1%
2/65
|
0.00%
0/65
|
3.2%
2/62
|
|
Infections and infestations
Bronchitis
|
1.5%
1/65
|
0.00%
0/65
|
3.2%
2/62
|
|
Infections and infestations
Gastrointeritis
|
0.00%
0/65
|
1.5%
1/65
|
3.2%
2/62
|
|
Infections and infestations
Rash pustular
|
0.00%
0/65
|
3.1%
2/65
|
0.00%
0/62
|
|
Nervous system disorders
Headache
|
6.2%
4/65
|
15.4%
10/65
|
6.5%
4/62
|
|
Gastrointestinal disorders
Diarrhea
|
1.5%
1/65
|
1.5%
1/65
|
6.5%
4/62
|
|
Gastrointestinal disorders
Nausea
|
3.1%
2/65
|
3.1%
2/65
|
3.2%
2/62
|
|
Investigations
Hepatic enzyme increased
|
3.1%
2/65
|
1.5%
1/65
|
0.00%
0/62
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.6%
3/65
|
3.1%
2/65
|
0.00%
0/62
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER