Trial Outcomes & Findings for Study of Live Attenuated Japanese Encephalitis Vaccine (ChimeriVax™-JE) and Yellow Fever Vaccine (STAMARIL®) (NCT NCT00982137)

Last Updated: 2012-09-20

Results Overview

Neutralising antibody titer against homologous Japanese encephalitis (JE), yellow fever (YF), and other relevant wild type JE strains were determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion post-vaccination was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-vaccination (Day 0) and the post-vaccination samples. The 30 Days post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

108 participants

Primary outcome timeframe

Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)

Results posted on

2012-09-20

Participant Flow

Participants were screened and enrolled from 27 July 2004 to 27 September 2004 at 1 clinical center in Australia.

A total of 108 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.

Participant milestones

Participant milestones
Measure	ChimeriVax™-JE Then STAMARIL® All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.	STAMARIL® Then ChimeriVax™-JE All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.	Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.	Diluent Then Coadministration With ChimeriVax-JE and STAMARIL® All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
Overall Study STARTED	36	36	18	18
Overall Study COMPLETED	36	35	18	17
Overall Study NOT COMPLETED	0	1	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	ChimeriVax™-JE Then STAMARIL® All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.	STAMARIL® Then ChimeriVax™-JE All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.	Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.	Diluent Then Coadministration With ChimeriVax-JE and STAMARIL® All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
Overall Study Lost to Follow-up	0	0	0	1
Overall Study Withdrawal by Subject	0	1	0	0

Baseline Characteristics

Study of Live Attenuated Japanese Encephalitis Vaccine (ChimeriVax™-JE) and Yellow Fever Vaccine (STAMARIL®)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ChimeriVax™-JE Then STAMARIL® n=36 Participants All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.	STAMARIL® Then ChimeriVax™-JE n=36 Participants All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.	Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent n=18 Participants All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.	Diluent Then Coadministration With ChimeriVax-JE and STAMARIL® n=18 Participants All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.	Total n=108 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	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants	36 Participants n=7 Participants	18 Participants n=5 Participants	18 Participants n=4 Participants	108 Participants n=21 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	0 Participants n=21 Participants
Age Continuous	27.2 Years STANDARD_DEVIATION 9.71 • n=5 Participants	23.4 Years STANDARD_DEVIATION 6.95 • n=7 Participants	27.5 Years STANDARD_DEVIATION 10.19 • n=5 Participants	25.8 Years STANDARD_DEVIATION 8.26 • n=4 Participants	25.8 Years STANDARD_DEVIATION 8.77 • n=21 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	13 Participants n=7 Participants	10 Participants n=5 Participants	7 Participants n=4 Participants	46 Participants n=21 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	23 Participants n=7 Participants	8 Participants n=5 Participants	11 Participants n=4 Participants	62 Participants n=21 Participants
Region of Enrollment Australia	36 Participants n=5 Participants	36 Participants n=7 Participants	18 Participants n=5 Participants	18 Participants n=4 Participants	108 Participants n=21 Participants

PRIMARY outcome

Timeframe: Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)

Population: Japanese encephalitis seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-Protocol Population).

Outcome measures

Outcome measures
Measure	ChimeriVax™-JE Then STAMARIL® n=17 Participants Participants received a single ChimeriVax™-JE on Day 0 and a single dose of STAMARIL® on Day 30.	STAMARIL® Then ChimeriVax™-JE n=23 Participants Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-J on Day 30.	Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent n=13 Participants Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.	Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL n=10 Participants Subjects received sc vaccination with diluent (both left and right arms) on Day 0, then sc vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
Number of Participants With Japanese Encephalitis Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination. Day 60 (N = 17, 23, 13, 10)	17 Participants	21 Participants	12 Participants	10 Participants
Number of Participants With Japanese Encephalitis Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination. 30 Days Post-JE Seroconversion (N = 17, 23, 23, 0)	17 Participants	21 Participants	22 Participants	NA Participants Data for the participants in Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL®, then Diluent) and Group 4, (Diluent then co-administration with ChimeriVax™-JE and STAMARIL) were pooled and presented in Group 3 column.
Number of Participants With Japanese Encephalitis Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination. Day 30 (N = 17, 23, 13, 10)	17 Participants	2 Participants Interval 0.0 to 0.0	12 Participants	0 Participants

PRIMARY outcome

Timeframe: Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)

Population: Yellow fever seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per Protocol Population).

Neutralising antibody titer against yellow fever strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint ws defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titre between the pre-injection Day 0 and later post vaccination samples. The Day 30 post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).

Outcome measures

Outcome measures
Measure	ChimeriVax™-JE Then STAMARIL® n=17 Participants Participants received a single ChimeriVax™-JE on Day 0 and a single dose of STAMARIL® on Day 30.	STAMARIL® Then ChimeriVax™-JE n=23 Participants Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-J on Day 30.	Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent n=13 Participants Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.	Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL n=10 Participants Subjects received sc vaccination with diluent (both left and right arms) on Day 0, then sc vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
Number of Participants With Yellow Fever Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL® or Placebo Vaccination. Day 30 (N = 17, 23, 13, 10)	0 Participants	23 Participants	13 Participants	1 Participants
Number of Participants With Yellow Fever Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL® or Placebo Vaccination. Day 60 (N = 17, 23, 13, 10)	17 Participants	23 Participants	13 Participants	10 Participants
Number of Participants With Yellow Fever Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL® or Placebo Vaccination. Day 30 Post-JE Seroconversion (N = 17, 23, 23, 0)	17 Participants	23 Participants	23 Participants	NA Participants Data for the participants in Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent) and Group 4, (Diluent then co-administration with ChimeriVax™-JE and STAMARIL) were pooled and presented in Group 3 column.

PRIMARY outcome

Timeframe: Day 0 (Pre-vaccination) through Day 30 post-vaccination

Neutralising antibody titer against homologous JE, YF, and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-injection Day 0 and post-vaccination samples.

Outcome measures

Outcome measures
Measure	ChimeriVax™-JE Then STAMARIL® n=17 Participants Participants received a single ChimeriVax™-JE on Day 0 and a single dose of STAMARIL® on Day 30.	STAMARIL® Then ChimeriVax™-JE n=23 Participants Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-J on Day 30.	Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent n=13 Participants Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.	Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL n=10 Participants Subjects received sc vaccination with diluent (both left and right arms) on Day 0, then sc vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination Genotype III	16 Participants	20 Participants	9 Participants	10 Participants
Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination Genotype IV	15 Participants	15 Participants	5 Participants	9 Participants
Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination JE Homologous Virus	17 Participants	21 Participants	12 Participants	10 Participants
Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination Genotype I	17 Participants	21 Participants	13 Participants	10 Participants
Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination Genotype II	15 Participants	16 Participants	9 Participants	9 Participants

PRIMARY outcome

Timeframe: Day 0 up to Day 60 post-vaccination

Population: Safety analyses were performed on data from all randomized subjects who received at least one dose of study medication: ChimeriVax JE, STAMARIL, or Diluent (Safety Population).

Solicited Local Adverse Events: Injection Site Pain, Erythema, Swelling, Hemorrhage, Venipuncture site Hemorrhage. Solicited Systemic Adverse Events: Fatigue, Malaise, Pyrexia, Chills, Headache, Dizziness, Myalgia, Abdominal Pain, Diarrhea, Nausea, Pharyngolaryngeal Pain. All solicited local reactions associated with ChimeriVax™-JE are presented in Group 1, those associated with STAMARIL® in Group 2, those associated with co-administered vaccines in Group 3, and those associated with diluent in Group 4. The solicited systemic adverse events are reported according to the participants' randomized study groups.

Outcome measures

Outcome measures
Measure	ChimeriVax™-JE Then STAMARIL® n=71 Participants Participants received a single ChimeriVax™-JE on Day 0 and a single dose of STAMARIL® on Day 30.	STAMARIL® Then ChimeriVax™-JE n=72 Participants Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-J on Day 30.	Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent n=36 Participants Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.	Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL n=36 Participants Subjects received sc vaccination with diluent (both left and right arms) on Day 0, then sc vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo Malaise (N = 36, 36, 18, 18)	10 Participants	12 Participants	2 Participants	6 Participants
Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo Pyrexia (N = 36, 36, 18, 18)	3 Participants	4 Participants	0 Participants	3 Participants
Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo Injection Site Pain (N = 71, 72, 36, 36)	13 Participants	13 Participants	6 Participants	4 Participants
Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo Injection Site Erythema (N = 71, 72, 36, 36)	6 Participants	9 Participants	3 Participants	1 Participants
Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo Injection Site Swelling (N = 71, 72, 36, 36)	4 Participants	0 Participants	3 Participants	1 Participants
Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo Injection Site Hemorrhage (N = 71, 72, 36, 36)	1 Participants	2 Participants	1 Participants	0 Participants
Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo Venipuncture Site Hemorrhage (N = 71, 72, 36, 36)	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo Fatigue (N = 36, 36, 18, 18)	16 Participants	15 Participants	3 Participants	10 Participants
Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo Chills (N = 36, 36, 18, 18)	1 Participants	4 Participants	1 Participants	2 Participants
Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo Headache (N = 36, 36, 18, 18)	18 Participants	20 Participants	6 Participants	8 Participants
Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo Dizziness (N = 36, 36, 18, 18)	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo Myalgia (N = 36, 36, 18, 18)	7 Participants	12 Participants	3 Participants	4 Participants
Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo Abdominal Pain (N = 36, 36, 18, 18)	5 Participants	4 Participants	2 Participants	3 Participants
Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo Diarrhea (N = 36, 36, 18, 18)	7 Participants	2 Participants	2 Participants	3 Participants
Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo Nausea (N = 36, 36, 18, 18)	3 Participants	1 Participants	1 Participants	2 Participants
Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo Pharyngolaryngeal Pain (N = 36, 36, 18, 18)	0 Participants	2 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 0 through 6 months post-vaccination

Population: GMTs were assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-protocol Population).

Neutralising antibody titer against homologous Japanese encephalitis (JE) and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test. Post-vaccination 15 (30) Days JE seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)

Outcome measures

Outcome measures
Measure	ChimeriVax™-JE Then STAMARIL® n=17 Participants Participants received a single ChimeriVax™-JE on Day 0 and a single dose of STAMARIL® on Day 30.	STAMARIL® Then ChimeriVax™-JE n=23 Participants Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-J on Day 30.	Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent n=13 Participants Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.	Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL n=10 Participants Subjects received sc vaccination with diluent (both left and right arms) on Day 0, then sc vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination. 15 Days Post-vaccination (N = 17, 23, 13, 10)	282.1 Titers Interval 130.8 to 608.3	140.2 Titers Interval 50.9 to 386.3	119.9 Titers Interval 53.6 to 267.9	386.5 Titers Interval 135.1 to 1106.4
Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination. 30 Days Post-vaccination (N = 17, 23, 13, 10)	1461.6 Titers Interval 632.8 to 3375.8	426.4 Titers Interval 172.3 to 1055.1	221.2 Titers Interval 94.9 to 515.3	611.6 Titers Interval 188.4 to 1986.0
Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination. 45 Days Post-vaccination (N = 17, 0, 13, 0)	1099.3 Titers Interval 465.9 to 2593.6	NA Titers Data were not assessed at this time point for this group.	146.3 Titers Interval 58.3 to 367.2	NA Titers Data were not assessed at this time point for this group.
Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination. 60 Days Post-vaccination (N = 17, 0, 13, 0)	687.8 Titers Interval 315.4 to 1499.8	NA Titers Data were not assessed at this time point for this group.	103.1 Titers Interval 43.9 to 242.1	NA Titers Data were not assessed at this time point for this group.
Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination. 6 Months Post-vaccination (N = 16, 22, 13, 10)	267.5 Titers Interval 122.4 to 584.4	134.0 Titers Interval 59.2 to 303.4	94.6 Titers Interval 37.8 to 236.9	99.9 Titers Interval 56.8 to 175.7

SECONDARY outcome

Timeframe: Day 0 through 6 months post-vaccination

Neutralising antibody titer against homologous yellow fever was determined using a 50% serum dilution plaque reduction neutralisation test. Post vaccination 15 (30) Days Yellow Fever seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).

Outcome measures

Outcome measures
Measure	ChimeriVax™-JE Then STAMARIL® n=17 Participants Participants received a single ChimeriVax™-JE on Day 0 and a single dose of STAMARIL® on Day 30.	STAMARIL® Then ChimeriVax™-JE n=23 Participants Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-J on Day 30.	Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent n=13 Participants Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.	Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL n=10 Participants Subjects received sc vaccination with diluent (both left and right arms) on Day 0, then sc vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
Geometric Mean Titers to Yellow Fever (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Day 15 Post-vaccination (N = 17, 23, 13, 10)	463.1 Titers Interval 156.2 to 1372.8	1080.7 Titers Interval 606.3 to 1926.2	1150.0 Titers Interval 527.3 to 2507.8	2044.1 Titers Interval 768.7 to 5435.2
Geometric Mean Titers to Yellow Fever (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Day 30 Post-vaccination (N = 17, 23, 13, 10)	3288.5 Titers Interval 1415.4 to 7640.4	3704.6 Titers Interval 2271.4 to 6042.0	1565.6 Titers Interval 897.9 to 2729.9	3054.9 Titers Interval 1230.2 to 7586.3
Geometric Mean Titers to Yellow Fever (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Day 45 Post-vaccination (N = 0, 23, 13, 0)	NA Titers Data were not assessed at this time point for this group.	2442.5 Titers Interval 1450.5 to 4112.8	974.6 Titers Interval 572.3 to 1659.8	NA Titers Data were not assessed at this time point for this group.
Geometric Mean Titers to Yellow Fever (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Day 60 Post-vaccination (N = 0, 23, 13, 0)	NA Titers Data were not assessed at this time point for this group.	2175.1 Titers Interval 1223.9 to 3865.4	653.1 Titers Interval 277.2 to 1539.0	NA Titers Data were not assessed at this time point for this group.
Geometric Mean Titers to Yellow Fever (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo 6 Months Post-vaccination (N = 16, 22, 13, 10)	2017.5 Titers Interval 842.0 to 4834.3	2058.7 Titers Interval 1302.5 to 3253.8	947.4 Titers Interval 431.3 to 2081.3	1351.8 Titers Interval 534.9 to 3416.4

Adverse Events

ChimeriVax™-JE Then STAMARIL®

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

STAMARIL® Then ChimeriVax™-JE

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ChimeriVax™-JE Then STAMARIL® n=71 participants at risk；n=36 participants at risk All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.	STAMARIL® Then ChimeriVax™-JE n=72 participants at risk；n=36 participants at risk All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.	Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent n=36 participants at risk；n=18 participants at risk All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.	Diluent Then Coadministration With ChimeriVax-JE and STAMARIL® n=36 participants at risk；n=18 participants at risk All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
General disorders Fatigue	44.4% 16/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	41.7% 15/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	16.7% 3/18 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	55.6% 10/18 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.
General disorders Injection Site Pain	18.3% 13/71 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	18.1% 13/72 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	16.7% 6/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	11.1% 4/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.
General disorders Injection Site Erythema	8.5% 6/71 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	12.5% 9/72 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	8.3% 3/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	2.8% 1/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.
General disorders Injection Site Swelling	5.6% 4/71 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	0.00% 0/72 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	8.3% 3/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	2.8% 1/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.
General disorders Malaise	27.8% 10/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	33.3% 12/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	11.1% 2/18 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	33.3% 6/18 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.
General disorders Pyrexia	8.3% 3/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	11.1% 4/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	0.00% 0/18 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	16.7% 3/18 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.
General disorders Chills	2.8% 1/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	11.1% 4/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	5.6% 1/18 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	11.1% 2/18 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.
Nervous system disorders Headache	50.0% 18/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	55.6% 20/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	33.3% 6/18 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	44.4% 8/18 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.
Nervous system disorders Dizziness	0.00% 0/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	5.6% 2/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	0.00% 0/18 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	0.00% 0/18 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.
Musculoskeletal and connective tissue disorders Myalgia	19.4% 7/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	33.3% 12/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	16.7% 3/18 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	22.2% 4/18 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.
Gastrointestinal disorders Abdominal Pain	13.9% 5/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	11.1% 4/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	11.1% 2/18 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	16.7% 3/18 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.
Gastrointestinal disorders Diarrhea	19.4% 7/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	5.6% 2/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	11.1% 2/18 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	16.7% 3/18 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.
Gastrointestinal disorders Nausea	8.3% 3/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	2.8% 1/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	5.6% 1/18 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	11.1% 2/18 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	0.00% 0/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	5.6% 2/36 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	0.00% 0/18 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.	5.6% 1/18 • Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination. Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: [email protected]

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