Trial Outcomes & Findings for A Study of Japanese Encephalitis Chimeric Virus Vaccine Compared With SA14-14-2 Vaccine in Infants and Toddlers (NCT NCT01092507)

Last Updated: 2013-12-25

Results Overview

Immunogenicity was assessed by the JE-CV virus and the SA14-14-2 virus 50% plaque reduction neutralization test (PRNT50). Japanese Encephalitis seroconversion was defined as a pre-vaccination titer \<10 1/dil and post-vaccination titer ≥ 10 1/dil; or a pre-vaccination titer ≥ 10 1/dil and a 4-fold increase from pre- to post-vaccination.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

300 participants

Primary outcome timeframe

Day 0 through Day 28 after vaccination

Results posted on

2013-12-25

Participant Flow

Participants were enrolled from 07 March 2010 to 27 April 2011 at 3 clinical centers in Thailand.

A total of 300 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled; 299 were vaccinated.

Participant milestones

Participant milestones
Measure	Japanese Encephalitis Chimeric Vaccine (JE-CV) Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.	Japanese Encephalitis Live Vaccine (SA14-14-2) Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
Overall Study STARTED	149	150
Overall Study COMPLETED	147	150
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Japanese Encephalitis Chimeric Vaccine (JE-CV) Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.	Japanese Encephalitis Live Vaccine (SA14-14-2) Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

A Study of Japanese Encephalitis Chimeric Virus Vaccine Compared With SA14-14-2 Vaccine in Infants and Toddlers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Japanese Encephalitis Chimeric Vaccine (JE-CV) n=149 Participants Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.	Japanese Encephalitis Live Vaccine (SA14-14-2) n=150 Participants Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.	Total n=299 Participants Total of all reporting groups
Age, Categorical <=18 years	149 Participants n=5 Participants	150 Participants n=7 Participants	299 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	13.1 Months STANDARD_DEVIATION 2.11 • n=5 Participants	13.2 Months STANDARD_DEVIATION 1.89 • n=7 Participants	13.2 Months STANDARD_DEVIATION 2.00 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	75 Participants n=7 Participants	144 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants	75 Participants n=7 Participants	155 Participants n=5 Participants
Region of Enrollment Thailand	149 Participants n=5 Participants	150 Participants n=7 Participants	299 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 through Day 28 after vaccination

Population: Japanese encephalitis antibody titers were assessed in all participants with immunogenicity data and who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)

Outcome measures

Outcome measures
Measure	Japanese Encephalitis Chimeric Vaccine (JE-CV) n=126 Participants Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.	Japanese Encephalitis Live Vaccine (SA14-14-2) n=128 Participants Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
Number of Participants With Japanese Encephalitis Seroconversion After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)	125 Participants	127 Participants

SECONDARY outcome

Timeframe: Day 28 post-vaccination

Population: Japanese encephalitis antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)

Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. Japanese encephalitis seroprotection defined as participant with antibody titer ≥ 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12.

Outcome measures

Outcome measures
Measure	Japanese Encephalitis Chimeric Vaccine (JE-CV) n=127 Participants Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.	Japanese Encephalitis Live Vaccine (SA14-14-2) n=129 Participants Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) Day 0, JE-CV PRNT50 (N = 127, 129)	0 Participants	0 Participants
Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) Day 28, JE-CV PRNT50 (N = 125, 128)	125 Participants	127 Participants
Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) Day 0, SA14-14-2 PRNT50 (N = 125, 128)	0 Participants	0 Participants
Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) Day 28, SA14-14-2 PRNT50 (N = 125, 126)	122 Participants	123 Participants

SECONDARY outcome

Timeframe: Day 28 post-vaccination

Population: Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)

Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. Seroconversion was defined as a pre-vaccination titer \< 10 1/dil and post vaccination titer ≥ 10 1/dil, or a pre-vaccination titer ≥ 10 and a 4-fold increase from pre- to post-vaccination.

Outcome measures

Outcome measures
Measure	Japanese Encephalitis Chimeric Vaccine (JE-CV) n=127 Participants Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.	Japanese Encephalitis Live Vaccine (SA14-14-2) n=129 Participants Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
Number of Participants With Seroconversion After Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®) JE-CV PRNT50 (N = 126, 128)	125 Participants	127 Participants
Number of Participants With Seroconversion After Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®) SA14-14-2 PRNT50 (N = 124, 125)	121 Participants	122 Participants

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccination

Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.

Outcome measures

Outcome measures
Measure	Japanese Encephalitis Chimeric Vaccine (JE-CV) n=127 Participants Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.	Japanese Encephalitis Live Vaccine (SA14-14-2) n=129 Participants Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) Day 0, JE-CV PRNT50 (N = 127, 129)	5.0 Titers Interval 5.0 to 5.0	5.0 Titers Interval 5.0 to 5.0
Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) Day 28, JE-CV PRNT50 (N = 126, 128)	491 Titers Interval 378.0 to 638.0	395 Titers Interval 304.0 to 514.0
Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) Day 0, SA14-14-2 PRNT50 (N = 125, 128)	5.00 Titers Interval 5.0 to 5.0	5.0 Titers Interval 5.0 to 5.0
Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) Day 28, SA14-14-2 PRNT50 (N = 125, 126)	205 Titers Interval 162.0 to 259.0	190 Titers Interval 152.0 to 239.0

SECONDARY outcome

Timeframe: Day 28 up to 12 months post-vaccination

Population: Japanese encephalitis antibody titers were assessed in all vaccinated participants with available immunogenicity data (Full Analysis Set)

Outcome measures

Outcome measures
Measure	Japanese Encephalitis Chimeric Vaccine (JE-CV) n=149 Participants Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.	Japanese Encephalitis Live Vaccine (SA14-14-2) n=150 Participants Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) Day 0, JE-CV PRNT50 (N = 149, 150)	6 Participants	5 Participants
Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) Day 28, JE-CV PRNT50 (N = 146, 148)	145 Participants	147 Participants
Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) Month 6, JE-CV PRNT50 (N = 145, 145)	137 Participants	141 Participants
Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) Month 12, JE-CV PRNT50 (N = 143, 146)	126 Participants	142 Participants
Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) Day 0, SA14-14-2 PRNT50 (N = 147, 149)	0 Participants	0 Participants
Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) Day 28, SA14-14-2 PRNT50 (N = 145, 146)	141 Participants	142 Participants
Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) Month 6, SA14-14-2 PRNT50 (N = 145, 145)	122 Participants	129 Participants
Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) Month 12, SA14-14-2 PRNT50 (N = 142, 144)	109 Participants	126 Participants

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination) and up to 12 months post-vaccination

Population: Japanese encephalitis antibody titers were assessed in all participants that received a vaccine and with available immunogenicity data (Full Analysis Set)

Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.

Outcome measures

Outcome measures
Measure	Japanese Encephalitis Chimeric Vaccine (JE-CV) n=149 Participants Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.	Japanese Encephalitis Live Vaccine (SA14-14-2) n=150 Participants Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) Month 6, JE-CV PRNT50 (N = 145, 145)	119 Titers Interval 91.7 to 154.0	103 Titers Interval 85.6 to 124.0
Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) Day 0, JE-CV PRNT50 (N = 149, 150)	5.39 Titers Interval 5.05 to 5.74	5.29 Titers Interval 4.98 to 5.61
Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) Day 28, JE-CV PRNT50 (N = 146, 148)	507 Titers Interval 395.0 to 651.0	370 Titers Interval 291.0 to 470.0
Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) Month 12, JE-CV PRNT50 (N = 143, 146)	97.6 Titers Interval 74.0 to 129.0	121 Titers Interval 96.7 to 151.0
Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) Day 0, SA14-14-2 PRNT50 (N = 147, 149)	5.00 Titers Interval 5.0 to 5.0	5.00 Titers Interval 5.0 to 5.0
Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) Day 28, SA14-14-2 PRNT50 (N = 145, 146)	198 Titers Interval 158.0 to 247.0	171 Titers Interval 138.0 to 212.0
Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) Month 6, SA14-14-2 PRNT50 (N = 145, 145)	52.7 Titers Interval 41.2 to 67.4	51.4 Titers Interval 41.6 to 63.6
Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) Month 12, SA14-14-2 PRNT50 (N = 142, 144)	46.5 Titers Interval 35.8 to 60.4	54.8 Titers Interval 43.9 to 68.4

SECONDARY outcome

Timeframe: Day 0 through Day 14 post-vaccination

Population: Solicited injection site and systemic reactions were assessed in all participants who received a study vaccination and for whom safety data were available, according to the vaccine actually received (Safety Population).

Solicited Injection Site Reactions: Tenderness, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, Irritability. Grade 3 Reactions defined as: Tenderness - crying when injected limb was moved, or movement of the injected limb was reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature \> 39.5ºC; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - \> 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite loss - refused ≥ 3 feeds or refused most feeds; and Irritability - inconsolable.

Outcome measures

Outcome measures
Measure	Japanese Encephalitis Chimeric Vaccine (JE-CV) n=147 Participants Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.	Japanese Encephalitis Live Vaccine (SA14-14-2) n=152 Participants Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) Any injection site Tenderness	44 Participants	57 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) Grade 3 injection site Tenderness	0 Participants	1 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) Any injection site Erythema	26 Participants	35 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) Grade 3 injection site Erythema	0 Participants	0 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) Any injection site Swelling	9 Participants	12 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) Grade 3 injection site Swelling	0 Participants	0 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) Any Fever	24 Participants	33 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) Grade 3 Fever	0 Participants	1 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) Any Vomiting	21 Participants	40 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) Grade 3 Vomiting	1 Participants	2 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) Any Crying Abnormal	28 Participants	39 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) Grade 3 Crying Abnormal	1 Participants	2 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) Any Drowsiness	25 Participants	38 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) Grade 3 Drowsiness	0 Participants	0 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) Any Appetite Loss	32 Participants	54 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) Grade 3 Appetite Loss	0 Participants	3 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) Any Irritability	41 Participants	58 Participants
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) Grade 3 Irritability	0 Participants	5 Participants

Adverse Events

Japanese Encephalitis Chimeric Vaccine (JE-CV)

Serious events: 14 serious events

Other events: 66 other events

Deaths: 0 deaths

Japanese Encephalitis Live Vaccine (SA14-14-2)

Serious events: 18 serious events

Other events: 88 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Japanese Encephalitis Chimeric Vaccine (JE-CV) n=147 participants at risk Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.	Japanese Encephalitis Live Vaccine (SA14-14-2) n=152 participants at risk Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
Gastrointestinal disorders Vomiting	14.4% 21/146 • Number of events 21 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	26.3% 40/152 • Number of events 40 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
General disorders Crying Abnormal	19.2% 28/146 • Number of events 28 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	25.7% 39/152 • Number of events 39 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
General disorders Injection Site Erythema	17.8% 26/146 • Number of events 26 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	23.0% 35/152 • Number of events 35 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
General disorders Injection Site Swelling	6.2% 9/146 • Number of events 9 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	7.9% 12/152 • Number of events 12 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
General disorders Injection Site Tenderness	30.1% 44/146 • Number of events 44 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	37.5% 57/152 • Number of events 57 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
General disorders Irritability	28.1% 41/146 • Number of events 41 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	38.2% 58/152 • Number of events 58 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
Infections and infestations Nasopharyngitis	9.5% 14/147 • Number of events 14 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	6.6% 10/152 • Number of events 12 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
Infections and infestations Pharyngitis	2.7% 4/147 • Number of events 4 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	5.9% 9/152 • Number of events 9 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
Infections and infestations Upper Respiratory Tract Infection	7.5% 11/147 • Number of events 12 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	20.4% 31/152 • Number of events 35 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
Metabolism and nutrition disorders Appetite Loss	21.9% 32/146 • Number of events 32 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	35.5% 54/152 • Number of events 54 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
Nervous system disorders Drowsiness	17.1% 25/146 • Number of events 25 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	25.0% 38/152 • Number of events 38 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
General disorders Fever	16.3% 24/147 • Number of events 24 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	21.7% 33/152 • Number of events 33 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: [email protected]

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

Measure	Japanese Encephalitis Chimeric Vaccine (JE-CV) n=147 participants at risk Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.	Japanese Encephalitis Live Vaccine (SA14-14-2) n=152 participants at risk Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
Gastrointestinal disorders Oesophageal Obstruction	0.00% 0/147 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	0.66% 1/152 • Number of events 1 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
Infections and infestations Anal Abscess	0.68% 1/147 • Number of events 1 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	0.00% 0/152 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
Infections and infestations Bronchitis	0.68% 1/147 • Number of events 1 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	1.3% 2/152 • Number of events 2 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
Infections and infestations Dengue Fever	0.68% 1/147 • Number of events 1 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	0.66% 1/152 • Number of events 1 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
Infections and infestations Diarrhoea Infectious	0.00% 0/147 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	0.66% 1/152 • Number of events 1 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
Infections and infestations Gastroenteritis	4.1% 6/147 • Number of events 6 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	0.66% 1/152 • Number of events 1 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
Infections and infestations Gastroenteritis Rotavirus	0.00% 0/147 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	2.0% 3/152 • Number of events 3 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
Infections and infestations Gastroenteritis Viral	0.00% 0/147 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	0.66% 1/152 • Number of events 1 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
Infections and infestations Nasopharyngitis	0.00% 0/147 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	0.66% 1/152 • Number of events 1 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
Infections and infestations Pharyngitis	0.68% 1/147 • Number of events 1 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	0.00% 0/152 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
Infections and infestations Pneumonia	0.68% 1/147 • Number of events 1 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	0.00% 0/152 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
Infections and infestations Pneumonia Bacterial	0.00% 0/147 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	0.66% 1/152 • Number of events 1 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
Infections and infestations Pneumonia Respiratory Syncytial Viral	0.68% 1/147 • Number of events 1 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	0.66% 1/152 • Number of events 1 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
Infections and infestations Urinary Tract Infection Enterococcal	0.68% 1/147 • Number of events 1 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	0.00% 0/152 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
Infections and infestations Viral Infection	1.4% 2/147 • Number of events 2 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	0.66% 1/152 • Number of events 1 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
Nervous system disorders Febrile Convulsion	0.00% 0/147 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	2.6% 4/152 • Number of events 4 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
Reproductive system and breast disorders Balanitis	0.68% 1/147 • Number of events 1 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)	0.00% 0/152 • Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination. Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)