Trial Outcomes & Findings for Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling (NCT NCT00776230)
NCT ID: NCT00776230
Last Updated: 2016-05-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
304 participants
Primary outcome timeframe
56 days post 1st vaccination
Results posted on
2016-05-04
Participant Flow
Participant milestones
| Measure |
IC51 Cohort 1
vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: \~12 months after filling;
|
IC51 Cohort 2
vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: \~18 months after filling;
|
IC51 Cohort 3
vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: \~24 months after filling;
|
|---|---|---|---|
|
Overall Study
STARTED
|
99
|
103
|
102
|
|
Overall Study
Enrolled and Vaccinated at Day 0
|
98
|
103
|
102
|
|
Overall Study
COMPLETED
|
96
|
100
|
97
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
5
|
Reasons for withdrawal
| Measure |
IC51 Cohort 1
vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: \~12 months after filling;
|
IC51 Cohort 2
vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: \~18 months after filling;
|
IC51 Cohort 3
vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: \~24 months after filling;
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
5
|
|
Overall Study
Not vaccinated at Day 0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Subject missed Visit 4
|
0
|
1
|
0
|
Baseline Characteristics
Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling
Baseline characteristics by cohort
| Measure |
IC51 Cohort 1
n=98 Participants
vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: \~12 months after filling;
|
IC51 Cohort 2
n=103 Participants
vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: \~18 months after filling;
|
IC51 Cohort 3
n=102 Participants
vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: \~24 months after filling;
|
Total
n=303 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
27.3 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
28.6 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
31.6 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
29.2 years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian/ White
|
93 participants
n=5 Participants
|
98 participants
n=7 Participants
|
102 participants
n=5 Participants
|
293 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
0 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 56 days post 1st vaccinationPopulation: Intention To Treat Population, i.e., all subjects entered into the study who received at least one dose of study medication
Outcome measures
| Measure |
IC51 Cohort 1
n=98 Participants
vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: \~12 months after filling;
|
IC51 Cohort 2
n=103 Participants
vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: \~18 months after filling;
|
IC51 Cohort 3
n=102 Participants
vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: \~24 months after filling;
|
|---|---|---|---|
|
Primary: 1. Geometric Mean Titers (GMT) at Day 56
|
100.1 Geometric Mean Titer - Estimate
Interval 78.9 to 127.0
|
84.7 Geometric Mean Titer - Estimate
Interval 66.3 to 108.2
|
68.1 Geometric Mean Titer - Estimate
Interval 54.4 to 85.4
|
SECONDARY outcome
Timeframe: see aboveOutcome measures
Outcome data not reported
Adverse Events
IC51 Cohort 1
Serious events: 2 serious events
Other events: 66 other events
Deaths: 0 deaths
IC51 Cohort 2
Serious events: 1 serious events
Other events: 58 other events
Deaths: 0 deaths
IC51 Cohort 3
Serious events: 0 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IC51 Cohort 1
n=98 participants at risk
|
IC51 Cohort 2
n=103 participants at risk
|
IC51 Cohort 3
n=102 participants at risk
|
|---|---|---|---|
|
Infections and infestations
Subcutaneous abscess
|
1.0%
1/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
1.0%
1/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Vascular disorders
Hypertension
|
0.00%
0/98 • up to Day 56
|
0.97%
1/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
Other adverse events
| Measure |
IC51 Cohort 1
n=98 participants at risk
|
IC51 Cohort 2
n=103 participants at risk
|
IC51 Cohort 3
n=102 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/98 • up to Day 56
|
1.9%
2/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Cardiac disorders
Tachycardia
|
1.0%
1/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
2/98 • up to Day 56
|
0.97%
1/103 • up to Day 56
|
2.0%
2/102 • up to Day 56
|
|
Eye disorders
Ocular Hyperaemia
|
1.0%
1/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.0%
1/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Gastrointestinal disorders
Dental Caries
|
1.0%
1/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
2.9%
3/102 • up to Day 56
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/98 • up to Day 56
|
1.9%
2/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Gastrointestinal disorders
Enteritis
|
1.0%
1/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Gastrointestinal disorders
Nausea
|
5.1%
5/98 • up to Day 56
|
4.9%
5/103 • up to Day 56
|
6.9%
7/102 • up to Day 56
|
|
Gastrointestinal disorders
Toothache
|
1.0%
1/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
0.98%
1/102 • up to Day 56
|
|
General disorders
Asthenia
|
1.0%
1/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
General disorders
Fatigue
|
3.1%
3/98 • up to Day 56
|
19.4%
20/103 • up to Day 56
|
9.8%
10/102 • up to Day 56
|
|
General disorders
Influenza Like Illness
|
13.3%
13/98 • up to Day 56
|
9.7%
10/103 • up to Day 56
|
14.7%
15/102 • up to Day 56
|
|
General disorders
Injection Site Erythema
|
1.0%
1/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
General disorders
Pyrexia
|
0.00%
0/98 • up to Day 56
|
1.9%
2/103 • up to Day 56
|
0.98%
1/102 • up to Day 56
|
|
Infections and infestations
Cystitis
|
1.0%
1/98 • up to Day 56
|
1.9%
2/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Infections and infestations
Gastroenteritis
|
3.1%
3/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
2.0%
2/102 • up to Day 56
|
|
Infections and infestations
Nasopharyngitis
|
11.2%
11/98 • up to Day 56
|
6.8%
7/103 • up to Day 56
|
6.9%
7/102 • up to Day 56
|
|
Infections and infestations
Rhinitis
|
5.1%
5/98 • up to Day 56
|
0.97%
1/103 • up to Day 56
|
2.0%
2/102 • up to Day 56
|
|
Infections and infestations
Sinusitis
|
1.0%
1/98 • up to Day 56
|
0.97%
1/103 • up to Day 56
|
0.98%
1/102 • up to Day 56
|
|
Infections and infestations
Subcutaneous Abscess
|
1.0%
1/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/98 • up to Day 56
|
1.9%
2/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Infections and infestations
Urinary Tract Infection
|
2.0%
2/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
2.0%
2/102 • up to Day 56
|
|
Investigations
Hepatic Enzyme Increased
|
1.0%
1/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Investigations
Iron Deficiency
|
0.00%
0/98 • up to Day 56
|
1.9%
2/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
1/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.0%
2/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
1.0%
1/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
7/98 • up to Day 56
|
8.7%
9/103 • up to Day 56
|
8.8%
9/102 • up to Day 56
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
1.0%
1/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Nervous system disorders
Disturbance In Attention
|
1.0%
1/98 • up to Day 56
|
0.97%
1/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Nervous system disorders
Dizziness
|
1.0%
1/98 • up to Day 56
|
2.9%
3/103 • up to Day 56
|
2.0%
2/102 • up to Day 56
|
|
Nervous system disorders
Headache
|
26.5%
26/98 • up to Day 56
|
23.3%
24/103 • up to Day 56
|
31.4%
32/102 • up to Day 56
|
|
Nervous system disorders
Paraesthesia
|
1.0%
1/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Renal and urinary disorders
Dysuria
|
1.0%
1/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Reproductive system and breast disorders
Endometrial Hyperplasia
|
1.0%
1/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Reproductive system and breast disorders
Endometriosis
|
1.0%
1/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.0%
1/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
3.1%
3/98 • up to Day 56
|
2.9%
3/103 • up to Day 56
|
2.0%
2/102 • up to Day 56
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/98 • up to Day 56
|
1.9%
2/103 • up to Day 56
|
0.00%
0/102 • up to Day 56
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/98 • up to Day 56
|
0.00%
0/103 • up to Day 56
|
2.0%
2/102 • up to Day 56
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER