Trial Outcomes & Findings for Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis. (NCT NCT00314132)
NCT ID: NCT00314132
Last Updated: 2012-12-06
Results Overview
Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered "actively solicited" through Day 30.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2004 participants
Primary outcome timeframe
Day 0 up to 30 days post-vaccination
Results posted on
2012-12-06
Participant Flow
Participants were enrolled and vaccinated from 10 October 2005 to 30 March 2006 at 6 clinical centers in Australia and 16 clinical centers in the US.
A total of 2004 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Placebo
Participants received a single injection of placebo on Day 0.
|
ChimeriVax™-JE 4 log10 PFU Vaccine
Participants received a single injection of ChimeriVax™-JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0.
|
|---|---|---|
|
Overall Study
STARTED
|
403
|
1601
|
|
Overall Study
COMPLETED
|
395
|
1583
|
|
Overall Study
NOT COMPLETED
|
8
|
18
|
Reasons for withdrawal
| Measure |
Placebo
Participants received a single injection of placebo on Day 0.
|
ChimeriVax™-JE 4 log10 PFU Vaccine
Participants received a single injection of ChimeriVax™-JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
13
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
Baseline characteristics by cohort
| Measure |
Placebo
n=403 Participants
Participants received a single injection of placebo on Day 0.
|
ChimeriVax™-JE 4 log10 PFU Vaccine
n=1601 Participants
Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
|
Total
n=2004 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
|
|
Age, Categorical
Between 18 and 65 years
|
403 Participants
n=5 Participants
|
1601 Participants
n=7 Participants
|
2004 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
34.8 Years
STANDARD_DEVIATION 14.12 • n=5 Participants
|
34.6 Years
STANDARD_DEVIATION 14.25 • n=7 Participants
|
34.7 Years
STANDARD_DEVIATION 14.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
165 Participants
n=5 Participants
|
721 Participants
n=7 Participants
|
886 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
238 Participants
n=5 Participants
|
880 Participants
n=7 Participants
|
1118 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
263 Participants
n=5 Participants
|
1201 Participants
n=7 Participants
|
1464 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
140 Participants
n=5 Participants
|
400 Participants
n=7 Participants
|
540 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 up to 30 days post-vaccinationPopulation: Treatment related adverse events were assessed in all participants who received an injection of study treatment, according to the treatment they received (Safety Population).
Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered "actively solicited" through Day 30.
Outcome measures
| Measure |
Placebo
n=403 Participants
All subjects received a single injection of placebo on Day 0.
|
ChimeriVax™-JE 4 log10 PFU Vaccine
n=1601 Participants
All participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
|
|---|---|---|
|
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Feeling Hot
|
27 Participants
|
152 Participants
|
|
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Chills
|
17 Participants
|
112 Participants
|
|
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Myalgia
|
48 Participants
|
265 Participants
|
|
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Nasopharyngitis
|
13 Participants
|
10 Participants
|
|
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Fatigue
|
90 Participants
|
365 Participants
|
|
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Malaise
|
69 Participants
|
297 Participants
|
|
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Injection Site Pain
|
36 Participants
|
199 Participants
|
|
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Injection Site Erythema
|
14 Participants
|
74 Participants
|
|
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Injection Site Pruritus
|
11 Participants
|
64 Participants
|
|
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Headache
|
99 Participants
|
417 Participants
|
|
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Arthralgia
|
21 Participants
|
119 Participants
|
|
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Diarrhea
|
25 Participants
|
140 Participants
|
|
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Nausea
|
26 Participants
|
114 Participants
|
|
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Abdominal Pain
|
21 Participants
|
89 Participants
|
|
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Pharyngolaryngeal Pain
|
10 Participants
|
55 Participants
|
|
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Dyspnea
|
10 Participants
|
53 Participants
|
|
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Nasal Congestion
|
9 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Day 0 up to 30 days post-vaccinationPopulation: Treatment emergent local adverse reactions and systemic reactions were assessed in all participants who received an injection of study treatment, according to the treatment they received (Safety Population).
Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported. Treatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported.
Outcome measures
| Measure |
Placebo
n=403 Participants
All subjects received a single injection of placebo on Day 0.
|
ChimeriVax™-JE 4 log10 PFU Vaccine
n=1601 Participants
All participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
|
|---|---|---|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Injection Site Pain
|
36 Participants
|
199 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Injection Site Hemorrhage
|
4 Participants
|
21 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Injection Site Induration
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Injection Site Stinging
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Fatigue
|
112 Participants
|
479 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Malaise
|
92 Participants
|
383 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Myalgia
|
67 Participants
|
352 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Arthralgia
|
28 Participants
|
179 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Nausea
|
37 Participants
|
164 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Rash
|
13 Participants
|
34 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Vomiting
|
12 Participants
|
37 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Injection Site Erythema
|
15 Participants
|
74 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Injection Site Pruritus
|
12 Participants
|
66 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Injection Site Swelling
|
4 Participants
|
17 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Injection Site Reaction
|
3 Participants
|
10 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Injection Site Rash
|
3 Participants
|
5 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Injection Site Joint Pain
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Injection Site Paresthesia
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Injection Site Warmth
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Chills
|
26 Participants
|
147 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Pyrexia
|
7 Participants
|
26 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Headache
|
124 Participants
|
597 Participants
|
|
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Diarrhea
|
36 Participants
|
183 Participants
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 124 other events
Deaths: 0 deaths
ChimeriVax™-JE 4 log10 PFU Vaccine
Serious events: 5 serious events
Other events: 597 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=403 participants at risk
Participants received a single injection of placebo on Day 0.
|
ChimeriVax™-JE 4 log10 PFU Vaccine
n=1601 participants at risk
Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
|
|---|---|---|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/403 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
0.06%
1/1601 • Number of events 1 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
|
General disorders
Pyrexia
|
0.00%
0/403 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
0.06%
1/1601 • Number of events 1 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
|
Infections and infestations
Streptococcal Sepsis
|
0.25%
1/403 • Number of events 1 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
0.00%
0/1601 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/403 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
0.06%
1/1601 • Number of events 1 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/403 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
0.06%
1/1601 • Number of events 1 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
|
Reproductive system and breast disorders
Fallopian Tube Cyst
|
0.00%
0/403 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
0.06%
1/1601 • Number of events 1 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.25%
1/403 • Number of events 1 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
0.00%
0/1601 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
Other adverse events
| Measure |
Placebo
n=403 participants at risk
Participants received a single injection of placebo on Day 0.
|
ChimeriVax™-JE 4 log10 PFU Vaccine
n=1601 participants at risk
Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
8.9%
36/403 • Number of events 42 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
11.4%
183/1601 • Number of events 251 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
|
Gastrointestinal disorders
Nausea
|
9.2%
37/403 • Number of events 50 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
10.2%
164/1601 • Number of events 228 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.5%
26/403 • Number of events 33 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
8.6%
138/1601 • Number of events 219 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
|
General disorders
Chills
|
6.5%
26/403 • Number of events 38 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
9.2%
147/1601 • Number of events 193 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
|
General disorders
Feeling Hot
|
8.7%
35/403 • Number of events 55 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
12.1%
193/1601 • Number of events 281 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
|
General disorders
Injection Site Pain
|
8.9%
36/403 • Number of events 51 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
12.4%
199/1601 • Number of events 279 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
|
General disorders
Malaise
|
22.8%
92/403 • Number of events 150 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
23.9%
383/1601 • Number of events 664 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.6%
67/403 • Number of events 104 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
22.0%
352/1601 • Number of events 561 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
28/403 • Number of events 44 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
11.2%
179/1601 • Number of events 259 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
|
Nervous system disorders
Headache
|
30.8%
124/403 • Number of events 251 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
37.3%
597/1601 • Number of events 1253 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
5.7%
23/403 • Number of events 33 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
5.6%
89/1601 • Number of events 122 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
|
General disorders
Fatigue
|
22.3%
90/403 • Number of events 141 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
22.8%
365/1601 • Number of events 699 • Adverse events data were collected from Day 0 to Month 6 post vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER