Trial Outcomes & Findings for A Study of ChimeriVax™-JE Live Attenuated Vaccine in Healthy Adults (NCT NCT00981175)
NCT ID: NCT00981175
Last Updated: 2012-07-16
Results Overview
Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
202 participants
Primary outcome timeframe
Day 28 post-vaccination
Results posted on
2012-07-16
Participant Flow
Participants were enrolled and vaccinated from 14 April 2003 to 05 January 2004 at 1 clinical center in Australia.
A total of 202 participants who met the inclusion/exclusion criteria were enrolled and vaccinated. A subset of the participants also received a booster vaccine at month 6. A report on all participants who received the primary and booster vaccination and the primary vaccination only are presented.
Participant milestones
| Measure |
ChimeriVax™-JE Vaccine First, Then Placebo
Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on day 28.
|
Placebo First, Then ChimeriVax™-JE Vaccine
Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on day 28.
|
|---|---|---|
|
Primary Dose Vaccination
STARTED
|
101
|
101
|
|
Primary Dose Vaccination
COMPLETED
|
98
|
99
|
|
Primary Dose Vaccination
NOT COMPLETED
|
3
|
2
|
|
Booster Dose Vaccination
STARTED
|
55
|
43
|
|
Booster Dose Vaccination
COMPLETED
|
53
|
40
|
|
Booster Dose Vaccination
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
ChimeriVax™-JE Vaccine First, Then Placebo
Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on day 28.
|
Placebo First, Then ChimeriVax™-JE Vaccine
Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on day 28.
|
|---|---|---|
|
Primary Dose Vaccination
Adverse Event
|
1
|
0
|
|
Primary Dose Vaccination
Protocol Violation
|
0
|
1
|
|
Primary Dose Vaccination
Lost to Follow-up
|
2
|
1
|
|
Booster Dose Vaccination
Lost to Follow-up
|
2
|
3
|
Baseline Characteristics
A Study of ChimeriVax™-JE Live Attenuated Vaccine in Healthy Adults
Baseline characteristics by cohort
| Measure |
ChimeriVax™-JE Vaccine First , Then Placebo
n=101 Participants
Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on Day 28.
|
Placebo First, Then ChimeriVax™-JE Vaccine
n=101 Participants
Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on Day 28.
|
Booster ChimeriVax™-JE Vaccine
Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Categorical
<=18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
—
|
0 participants
n=4 Participants
|
|
Age Categorical
Between 18 and 65 years
|
101 participants
n=5 Participants
|
101 participants
n=7 Participants
|
—
|
202 participants
n=4 Participants
|
|
Age Categorical
>=65 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
—
|
0 participants
n=4 Participants
|
|
Age Continuous
|
26.1 Years
STANDARD_DEVIATION 7.36 • n=5 Participants
|
27.7 Years
STANDARD_DEVIATION 8.25 • n=7 Participants
|
—
|
26.9 Years
STANDARD_DEVIATION 7.84 • n=4 Participants
|
|
Gender
Female
|
13 participants
n=5 Participants
|
15 participants
n=7 Participants
|
—
|
28 participants
n=4 Participants
|
|
Gender
Male
|
88 participants
n=5 Participants
|
86 participants
n=7 Participants
|
—
|
174 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
101 participants
n=5 Participants
|
101 participants
n=7 Participants
|
—
|
202 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 28 post-vaccinationPopulation: Immunogenicity was assessed in the Intent-to-Treat Population.
Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28.
Outcome measures
| Measure |
ChimeriVax™-JE Vaccine (Single or Primary)
n=201 Participants
Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
|
Booster ChimeriVax™-JE Vaccine
Participants received ChimeriVax™-JE vaccine booster at month 6.
|
No Booster Vaccine
Participants did not receive a booster dose Chimerivax™-JE vaccine
|
|---|---|---|---|
|
Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Dose
PRNT50 ≥ 10 [N = 197]
|
194 Participants
|
—
|
—
|
|
Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Dose
PRNT50 ≥ 20 [N = 197]
|
191 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 0 to 28 post-vaccinationPopulation: Injection site reactions were assessed in the Safety Population.
Injection Site Treatment Emergent Adverse Events: Pain, Reaction Not Otherwise Specified (NOS), Erythema, Swelling, Bruising, Nodule, Pigmentation Changes, Pruritus were assessed in all participants for up to 28 days post-Vaccination.
Outcome measures
| Measure |
ChimeriVax™-JE Vaccine (Single or Primary)
n=201 Participants
Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
|
Booster ChimeriVax™-JE Vaccine
n=199 Participants
Participants received ChimeriVax™-JE vaccine booster at month 6.
|
No Booster Vaccine
n=98 Participants
Participants did not receive a booster dose Chimerivax™-JE vaccine
|
|---|---|---|---|
|
Number of Participants Reporting Injection Site Treatment Emergent Adverse Events Post-Vaccination With ChimeriVax™-JE or Placebo at Day 0 and Day 28, and Following a Booster of ChimeriVax™-JE at Month 6 in a Subset of the Study Population.
Injection site Pain
|
7 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants Reporting Injection Site Treatment Emergent Adverse Events Post-Vaccination With ChimeriVax™-JE or Placebo at Day 0 and Day 28, and Following a Booster of ChimeriVax™-JE at Month 6 in a Subset of the Study Population.
Injection site Reaction NOS
|
6 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Injection Site Treatment Emergent Adverse Events Post-Vaccination With ChimeriVax™-JE or Placebo at Day 0 and Day 28, and Following a Booster of ChimeriVax™-JE at Month 6 in a Subset of the Study Population.
Injection site Erythema
|
4 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants Reporting Injection Site Treatment Emergent Adverse Events Post-Vaccination With ChimeriVax™-JE or Placebo at Day 0 and Day 28, and Following a Booster of ChimeriVax™-JE at Month 6 in a Subset of the Study Population.
Injection site Swelling
|
2 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants Reporting Injection Site Treatment Emergent Adverse Events Post-Vaccination With ChimeriVax™-JE or Placebo at Day 0 and Day 28, and Following a Booster of ChimeriVax™-JE at Month 6 in a Subset of the Study Population.
Injection site Bruising
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Injection Site Treatment Emergent Adverse Events Post-Vaccination With ChimeriVax™-JE or Placebo at Day 0 and Day 28, and Following a Booster of ChimeriVax™-JE at Month 6 in a Subset of the Study Population.
Injection site Nodule
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Injection Site Treatment Emergent Adverse Events Post-Vaccination With ChimeriVax™-JE or Placebo at Day 0 and Day 28, and Following a Booster of ChimeriVax™-JE at Month 6 in a Subset of the Study Population.
Injection site Pigmentation Changes
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Injection Site Treatment Emergent Adverse Events Post-Vaccination With ChimeriVax™-JE or Placebo at Day 0 and Day 28, and Following a Booster of ChimeriVax™-JE at Month 6 in a Subset of the Study Population.
Injection site Pruritus
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 6 pre- and post-vaccinationPopulation: Immunogenicity was assessed in the Intent to Treat Population pre- and post-booster vaccination.
Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and pre- and post-Booster vaccination.
Outcome measures
| Measure |
ChimeriVax™-JE Vaccine (Single or Primary)
Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
|
Booster ChimeriVax™-JE Vaccine
n=97 Participants
Participants received ChimeriVax™-JE vaccine booster at month 6.
|
No Booster Vaccine
n=103 Participants
Participants did not receive a booster dose Chimerivax™-JE vaccine
|
|---|---|---|---|
|
Number of Participants With Seroconversion to Homologous ChimeriVax™-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed by a Booster Vaccine Dose.
Pre-booster PRNT50 ≥ 10 [N = 0, 98, 93]
|
—
|
95 Participants
|
90 Participants
|
|
Number of Participants With Seroconversion to Homologous ChimeriVax™-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed by a Booster Vaccine Dose.
Post-booster PRNT50 ≥ 10 [N = 0, 97, 0]
|
—
|
97 Participants
|
NA Participants
Participants did not receive treatment
|
|
Number of Participants With Seroconversion to Homologous ChimeriVax™-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed by a Booster Vaccine Dose.
Pre-booster PRNT50 ≥ 20 [N = 0, 98, 93]
|
—
|
93 Participants
|
87 Participants
|
|
Number of Participants With Seroconversion to Homologous ChimeriVax™-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed by a Booster Vaccine Dose.
Post-booster PRNT50 ≥ 20 [N = 0, 97, 0]
|
—
|
97 Participants
|
NA Participants
Participants did not receive treatment
|
SECONDARY outcome
Timeframe: Month 12 post-vaccinationPopulation: Immunogenicity was assessed in the Intent to Treat Population
Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and followed or not by a booster vaccine dose at 6 month.
Outcome measures
| Measure |
ChimeriVax™-JE Vaccine (Single or Primary)
Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
|
Booster ChimeriVax™-JE Vaccine
n=97 Participants
Participants received ChimeriVax™-JE vaccine booster at month 6.
|
No Booster Vaccine
n=103 Participants
Participants did not receive a booster dose Chimerivax™-JE vaccine
|
|---|---|---|---|
|
Number of Participants With Seroconversion to Homologous ChimeriVax™-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed or Not by a Booster Vaccine Dose at 6 Month.
PRNT50 ≥ 10 [N = 0, 80, 76]
|
—
|
79 Participants
|
72 Participants
|
|
Number of Participants With Seroconversion to Homologous ChimeriVax™-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed or Not by a Booster Vaccine Dose at 6 Month.
PRNT50 ≥ 20 [N = 0, 80, 76]
|
—
|
78 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: Month 24 post-vaccinationPopulation: Immunogenicity was assessed in the Intent to Treat Population
Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and followed or not by a booster vaccine dose at month 24.
Outcome measures
| Measure |
ChimeriVax™-JE Vaccine (Single or Primary)
Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
|
Booster ChimeriVax™-JE Vaccine
n=97 Participants
Participants received ChimeriVax™-JE vaccine booster at month 6.
|
No Booster Vaccine
n=103 Participants
Participants did not receive a booster dose Chimerivax™-JE vaccine
|
|---|---|---|---|
|
Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed or Not by a Booster Vaccine Dose at 6 Month.
PRNT50 ≥ 10 [N = 0, 70, 71]
|
—
|
69 Participants
|
64 Participants
|
|
Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed or Not by a Booster Vaccine Dose at 6 Month.
PRNT50 ≥ 20 [N = 0, 70, 71]
|
—
|
67 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: Day 0 up to 28 post-vaccinationPopulation: Treatment emergent adverse events were assessed in the Safety Population.
Treatment emergent adverse events were assessed in all participants receiving ChimeriVax-JE Vaccine, Diluent (Placebo), or Booster Vaccination.
Outcome measures
| Measure |
ChimeriVax™-JE Vaccine (Single or Primary)
n=201 Participants
Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
|
Booster ChimeriVax™-JE Vaccine
n=199 Participants
Participants received ChimeriVax™-JE vaccine booster at month 6.
|
No Booster Vaccine
n=98 Participants
Participants did not receive a booster dose Chimerivax™-JE vaccine
|
|---|---|---|---|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Any Adverse Event
|
47 Participants
|
45 Participants
|
4 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Headache
|
12 Participants
|
10 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Injection Site Pain
|
7 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Injection Site Reaction Not Otherwise Specified
|
6 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Lethargy
|
5 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Viral Infection Not Otherwise Specified
|
5 Participants
|
10 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Injection Site Erythema
|
4 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Fatigue
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Lymphadenopathy
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Injection Site Swelling
|
2 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Diarrhea Not Otherwise Specified
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Nausea
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Pyrexia
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Liver Function Test Abnormal
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Myalgia
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Upper Respiratory Tract Infection NOS
|
2 Participants
|
9 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Vomiting Not Otherwise Specified
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Injection Site Bruising
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Injection Site Nodule
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Injection Site Pigmentation Changes
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Injection Site Pruritus
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Malaise
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Rigors
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Gastroenteritis Not Otherwise Specified
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Anorexia
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Pharygolaryngeal Pain
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Insomnia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Dry Eyes Not Otherwise Specified
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Disturbance in Attention
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Contusion
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Flushing
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
ChimeriVax™-JE Vaccine First , Then Placebo
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo First, Then ChimeriVax™-JE Vaccine
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Booster ChimeriVax™-JE Vaccine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ChimeriVax™-JE Vaccine First , Then Placebo
n=201 participants at risk
Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on Day 28.
|
Placebo First, Then ChimeriVax™-JE Vaccine
n=199 participants at risk
Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on Day 28.
|
Booster ChimeriVax™-JE Vaccine
n=98 participants at risk
Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28
|
|---|---|---|---|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.50%
1/201 • Number of events 1 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/199 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/98 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Infections and infestations
Gastroenteritis Not Otherwise Specified
|
0.50%
1/201 • Number of events 1 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/199 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/98 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Infections and infestations
Viral Infection Not Otherwise Specified
|
0.00%
0/201 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.50%
1/199 • Number of events 1 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/98 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
Other adverse events
| Measure |
ChimeriVax™-JE Vaccine First , Then Placebo
n=201 participants at risk
Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on Day 28.
|
Placebo First, Then ChimeriVax™-JE Vaccine
n=199 participants at risk
Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on Day 28.
|
Booster ChimeriVax™-JE Vaccine
n=98 participants at risk
Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea Not Otherwise Specified
|
1.00%
2/201 • Number of events 2 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
3.0%
6/199 • Number of events 6 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
General disorders
Injection Site Pain
|
3.5%
7/201 • Number of events 7 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
2.5%
5/199 • Number of events 5 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/98 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
General disorders
Injection Site Reaction Not Otherwise Specified
|
3.0%
6/201 • Number of events 6 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
2.0%
4/199 • Number of events 4 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/98 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
General disorders
Injection Site Swelling
|
1.00%
2/201 • Number of events 2 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
3.0%
6/199 • Number of events 6 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
General disorders
Lethargy
|
5.5%
11/201 • Number of events 11 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
2.5%
5/199 • Number of events 5 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
General disorders
Pyrexia
|
1.00%
2/201 • Number of events 2 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
1.5%
3/199 • Number of events 3 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
3.1%
3/98 • Number of events 3 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Infections and infestations
Upper Respiratory Tract Infection NOS
|
11.9%
24/201 • Number of events 27 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
17.6%
35/199 • Number of events 38 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Infections and infestations
Viral Infection Not Otherwise Specified
|
2.5%
5/201 • Number of events 5 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
5.5%
11/199 • Number of events 11 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
0.00%
0/98 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
|
Nervous system disorders
Headache
|
13.4%
27/201 • Number of events 31 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
10.1%
20/199 • Number of events 20 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
|
1.0%
1/98 • Number of events 1 • Adverse event data were collected from day of vaccination (Day 0) for up to 6 months 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