Trial Outcomes & Findings for Boosterability of Live Attenuated Japanese Encephalitis (JE) Vaccine in Children Who Have Previously Received Inactivated JE Vaccine (NCT NCT00463476)

Last Updated: 2020-03-31

Results Overview

Blood serum was collected immediately before administration (Day 0), Day 28, and 1 year later. Serum neutralizing antibodies to the Beijing-1 JE strain were measured by plaque reduction neutralization test (PRNT) where the neutralizing titer was measured as the inverse dilution at which plaque counts were reduced by 50%. Seropositivity was defined as a titer of ≥ 1:10.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

305 participants

Primary outcome timeframe

Day 0 (pre-vaccination) and 28 days and 1 year post-vaccination

Results posted on

2020-03-31

Participant Flow

Healthy children 2 and 5 years of age who had previously received two and three doses of inactivated mouse brain-derived vaccine (IMBV), respectively, were enrolled in the Colombo District of Sri Lanka between July and October 2007.

Participant milestones

Participant milestones
Measure	2-year Olds Healthy children 2 years of age who had previously received IMBV at the recommended 12 and 13 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.	5-year Olds Healthy children 5 years of age who had received IMBV at the recommended 12, 13, and 24 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.
Overall Study STARTED	151	154
Overall Study COMPLETED	149	151
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	2-year Olds Healthy children 2 years of age who had previously received IMBV at the recommended 12 and 13 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.	5-year Olds Healthy children 5 years of age who had received IMBV at the recommended 12, 13, and 24 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.
Overall Study Withdrawal by Subject	1	2
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Boosterability of Live Attenuated Japanese Encephalitis (JE) Vaccine in Children Who Have Previously Received Inactivated JE Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	2-year Olds n=151 Participants Healthy children 2 years of age who had previously received IMBV at the recommended 12 and 13 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.	5-year Olds n=154 Participants Healthy children 5 years of age who had received IMBV at the recommended 12, 13, and 24 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.	Total n=305 Participants Total of all reporting groups
Age, Continuous	24.5 months STANDARD_DEVIATION 1.4 • n=93 Participants	60.4 months STANDARD_DEVIATION 1.6 • n=4 Participants	42.6 months STANDARD_DEVIATION 18 • n=27 Participants
Sex: Female, Male Female	72 Participants n=93 Participants	78 Participants n=4 Participants	150 Participants n=27 Participants
Sex: Female, Male Male	79 Participants n=93 Participants	76 Participants n=4 Participants	155 Participants n=27 Participants
Region of Enrollment Sri Lanka	151 participants n=93 Participants	154 participants n=4 Participants	305 participants n=27 Participants

PRIMARY outcome

Timeframe: Day 0 (pre-vaccination) and 28 days and 1 year post-vaccination

Population: The per-protocol analysis set included all participants of the appropriate age at study entry (2 years of age ±3 months and 5 years of age ±3 months for each group respectively) who received LJEV at Day 0 and with valid serology laboratory results 28 days post-vaccination. Five participants did not complete the 1-year post-vaccination visit.

Outcome measures

Outcome measures
Measure	2-year Olds n=147 Participants Healthy children 2 years of age who had previously received IMBV at the recommended 12 and 13 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.	5-year Olds n=147 Participants Healthy children 5 years of age who had received IMBV at the recommended 12, 13, and 24 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.
Percentage of Participants With Demonstrated Seropositivity for Japanese Encephalitis (JE) Neutralizing Antibodies Day 0	98.0 percentage of participants Interval 94.2 to 99.6	99.3 percentage of participants Interval 96.3 to 100.0
Percentage of Participants With Demonstrated Seropositivity for Japanese Encephalitis (JE) Neutralizing Antibodies Day 28	100.0 percentage of participants Interval 97.5 to 100.0	100.0 percentage of participants Interval 97.5 to 100.0
Percentage of Participants With Demonstrated Seropositivity for Japanese Encephalitis (JE) Neutralizing Antibodies One year	100.0 percentage of participants Interval 97.5 to 100.0	99.3 percentage of participants Interval 96.2 to 100.0

SECONDARY outcome

Timeframe: Day 0 and 28 days and 1 year post-vaccination

Population: Per-protocol analysis set; 5 participants did not complete the 1-year post-vaccination visit.

Outcome measures

Outcome measures
Measure	2-year Olds n=147 Participants Healthy children 2 years of age who had previously received IMBV at the recommended 12 and 13 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.	5-year Olds n=147 Participants Healthy children 5 years of age who had received IMBV at the recommended 12, 13, and 24 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.
Geometric Mean Titer (GMT) of Japanese Encephalitis (JE) Neutralizing Antibodies Day 0	697 titer Interval 551.0 to 883.0	926 titer Interval 733.0 to 1170.0
Geometric Mean Titer (GMT) of Japanese Encephalitis (JE) Neutralizing Antibodies Day 28	3175 titer Interval 2744.0 to 3672.0	2776 titer Interval 2400.0 to 3210.0
Geometric Mean Titer (GMT) of Japanese Encephalitis (JE) Neutralizing Antibodies 1 year	3170 titer Interval 2674.0 to 3758.0	2585 titer Interval 2131.0 to 3136.0

SECONDARY outcome

Timeframe: Day 0 and 28 days and 1 year post-vaccination

Population: All enrolled participants who received at least one dose of the live JE vaccine. Not all participants were followed for a full 30 minutes after injection.

Participants were monitored for immediate AEs and local reactions for 30 minutes after each injection by a study physician. Thereafter, parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days afterwards. Study staff called the participants' parents 2 days after vaccination and monthly through 1 year to inquire about the child's well being and review the diary card. The participant was visited at home on Day 7 to review and collect the reactogenicity diary card. The participant returned to the vaccination clinic on Day 28, 6 months, and 1 year to be examined, have a blood draw, and review any AEs or serious adverse events (SAE) with parents.

Outcome measures

Outcome measures
Measure	2-year Olds n=151 Participants Healthy children 2 years of age who had previously received IMBV at the recommended 12 and 13 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.	5-year Olds n=154 Participants Healthy children 5 years of age who had received IMBV at the recommended 12, 13, and 24 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.
Number of Participants With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE) Unsolicited systemic reactions > 7 days	11 Participants	12 Participants
Number of Participants With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE) Any non-serious adverse events Days 8-28	54 Participants	54 Participants
Number of Participants With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE) Related adverse events at any time	0 Participants	1 Participants
Number of Participants With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE) Immediate reactions within 30 minutes	0 Participants	1 Participants
Number of Participants With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE) Solicited local reactions Days 0-3	31 Participants	46 Participants
Number of Participants With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE) Solicited local reactions Days 4-7	1 Participants	6 Participants
Number of Participants With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE) Solicited systemic reactions Days 0-7	44 Participants	38 Participants
Number of Participants With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE) Solicited systemic reactions > 7 days	12 Participants	5 Participants
Number of Participants With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE) Unsolicited systemic reactions Days 0-7	15 Participants	15 Participants
Number of Participants With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE) Serious adverse events, Days 8-365	22 Participants	8 Participants

SECONDARY outcome

Timeframe: 3 days post-vaccination

Population: All enrolled participants who received at least one dose of the live JE vaccine.

Parents recorded local reactions (redness, swelling, pain, and other local reactions) in a study diary. Events were assessed by the clinician to quantify intensity using the following guidelines: * Mild: Events required minimal or no treatment and do not interfere with the child's functioning. * Moderate: Events resulted in a low level of concern with therapeutic measures. Moderate events may cause some interference with functioning. * Severe: Events interrupted the child's functioning and may have required systemic drug therapy or other treatment. Severe events are usually incapacitating.

Outcome measures

Outcome measures
Measure	2-year Olds n=151 Participants Healthy children 2 years of age who had previously received IMBV at the recommended 12 and 13 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.	5-year Olds n=154 Participants Healthy children 5 years of age who had received IMBV at the recommended 12, 13, and 24 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.
Number of Participants Experiencing Solicited Local Reactions Up to 3 Days Post-vaccination Pain	28 Participants	44 Participants
Number of Participants Experiencing Solicited Local Reactions Up to 3 Days Post-vaccination Any local reactions	31 Participants	46 Participants
Number of Participants Experiencing Solicited Local Reactions Up to 3 Days Post-vaccination Mild local reactions	27 Participants	41 Participants
Number of Participants Experiencing Solicited Local Reactions Up to 3 Days Post-vaccination Moderate local reactions	4 Participants	5 Participants
Number of Participants Experiencing Solicited Local Reactions Up to 3 Days Post-vaccination Severe local reactions	0 Participants	0 Participants
Number of Participants Experiencing Solicited Local Reactions Up to 3 Days Post-vaccination Redness (Erythema)	7 Participants	7 Participants
Number of Participants Experiencing Solicited Local Reactions Up to 3 Days Post-vaccination Swelling	8 Participants	9 Participants

SECONDARY outcome

Timeframe: 7 days post-vaccination

Population: All enrolled participants who received at least one dose of the live JE vaccine.

Parents recorded axillary temperature and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days after vaccination. The participant was visited at home on Day 7 to review and collect the reactogenicity diary card. Events were assessed by the clinician to quantify intensity using the following guidelines: * Mild: Events required minimal or no treatment and do not interfere with the child's functioning. * Moderate: Events resulted in a low level of concern with therapeutic measures. Moderate events may cause some interference with functioning. * Severe: Events interrupted the child's functioning and may have required systemic drug therapy or other treatment. Severe events are usually incapacitating.

Outcome measures

Outcome measures
Measure	2-year Olds n=151 Participants Healthy children 2 years of age who had previously received IMBV at the recommended 12 and 13 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.	5-year Olds n=154 Participants Healthy children 5 years of age who had received IMBV at the recommended 12, 13, and 24 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.
Number of Participants Experiencing Solicited Systemic Reactions up to 7 Days Post-vaccination Fever: Any severity	12 Participants	16 Participants
Number of Participants Experiencing Solicited Systemic Reactions up to 7 Days Post-vaccination Insomnia: Severe	0 Participants	0 Participants
Number of Participants Experiencing Solicited Systemic Reactions up to 7 Days Post-vaccination Any systemic reaction	44 Participants	38 Participants
Number of Participants Experiencing Solicited Systemic Reactions up to 7 Days Post-vaccination Severe systemic reaction	1 Participants	1 Participants
Number of Participants Experiencing Solicited Systemic Reactions up to 7 Days Post-vaccination Fever: Severe	0 Participants	0 Participants
Number of Participants Experiencing Solicited Systemic Reactions up to 7 Days Post-vaccination Anorexia: Any severity	28 Participants	16 Participants
Number of Participants Experiencing Solicited Systemic Reactions up to 7 Days Post-vaccination Anorexia: Severe	0 Participants	1 Participants
Number of Participants Experiencing Solicited Systemic Reactions up to 7 Days Post-vaccination Crying: Any severity	15 Participants	8 Participants
Number of Participants Experiencing Solicited Systemic Reactions up to 7 Days Post-vaccination Crying: Severe	0 Participants	0 Participants
Number of Participants Experiencing Solicited Systemic Reactions up to 7 Days Post-vaccination Diarrhea: any severity	0 Participants	1 Participants
Number of Participants Experiencing Solicited Systemic Reactions up to 7 Days Post-vaccination Diarrhea: Severe	0 Participants	1 Participants
Number of Participants Experiencing Solicited Systemic Reactions up to 7 Days Post-vaccination Tiredness: Any	9 Participants	5 Participants
Number of Participants Experiencing Solicited Systemic Reactions up to 7 Days Post-vaccination Tiredness: Severe	0 Participants	0 Participants
Number of Participants Experiencing Solicited Systemic Reactions up to 7 Days Post-vaccination Insomnia: Any severity	13 Participants	5 Participants
Number of Participants Experiencing Solicited Systemic Reactions up to 7 Days Post-vaccination Irritability: Any severity	6 Participants	5 Participants
Number of Participants Experiencing Solicited Systemic Reactions up to 7 Days Post-vaccination Irritability: Severe	1 Participants	0 Participants
Number of Participants Experiencing Solicited Systemic Reactions up to 7 Days Post-vaccination Vomiting: Any severity	6 Participants	6 Participants
Number of Participants Experiencing Solicited Systemic Reactions up to 7 Days Post-vaccination Vomiting: Severe	0 Participants	0 Participants

POST_HOC outcome

Timeframe: Baseline (Day 0) and 28 days post-vaccination

Population: Per-protocol analysis set with baseline Japanese encephalitis (JE) neutralizing antibodies ≥ 10.

Compares geometric mean titers (GMT) for baseline and 28 days post-vaccination among participants seropositive for neutralizing antibodies against JE virus (titer of ≥1:10) at Baseline. Serum neutralizing antibodies to the Beijing-1 JE strain were measured by plaque reduction neutralization test (PRNT) where the neutralizing titer was measured as the inverse dilution at which plaque counts were reduced by 50%.

Outcome measures

Outcome measures
Measure	2-year Olds n=144 Participants Healthy children 2 years of age who had previously received IMBV at the recommended 12 and 13 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.	5-year Olds n=146 Participants Healthy children 5 years of age who had received IMBV at the recommended 12, 13, and 24 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.
Number of Participants With Baseline Japanese Encephalitis (JE) Neutralizing Antibodies ≥ 10 Experiencing Fold-level Increases in JE Neutralizing Antibodies From Pre-vaccination to 28 Days Post-vaccination < 2.00-fold increase	42 Participants	63 Participants
Number of Participants With Baseline Japanese Encephalitis (JE) Neutralizing Antibodies ≥ 10 Experiencing Fold-level Increases in JE Neutralizing Antibodies From Pre-vaccination to 28 Days Post-vaccination 2.00-2.99-fold increase	12 Participants	15 Participants
Number of Participants With Baseline Japanese Encephalitis (JE) Neutralizing Antibodies ≥ 10 Experiencing Fold-level Increases in JE Neutralizing Antibodies From Pre-vaccination to 28 Days Post-vaccination 3.00-3.99-fold increase	14 Participants	9 Participants
Number of Participants With Baseline Japanese Encephalitis (JE) Neutralizing Antibodies ≥ 10 Experiencing Fold-level Increases in JE Neutralizing Antibodies From Pre-vaccination to 28 Days Post-vaccination ≥ 4.00-fold increase	76 Participants	59 Participants

Adverse Events

2-year Olds

Serious events: 22 serious events

Other events: 54 other events

Deaths: 0 deaths

5-year Olds

Serious events: 8 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Jorge Flores

PATH

Phone: (202) 822-0033

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	2-year Olds n=151 participants at risk Healthy children 2 years of age who had previously received IMBV at the recommended 12 and 13 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.	5-year Olds n=154 participants at risk Healthy children 5 years of age who had received IMBV at the recommended 12, 13, and 24 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.
Gastrointestinal disorders Abdominal Pain	0.00% 0/151 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Gastrointestinal disorders Vomiting	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
General disorders Pyrexia	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Bacterial infection	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Cellulitis	0.00% 0/151 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Enterobiasis	0.00% 0/151 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Gastritis viral	0.00% 0/151 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Gastroenteritis	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Lower respiratory tract infection	3.3% 5/151 • Number of events 8 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Tonsillitis	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Upper respiratory tract infection	1.3% 2/151 • Number of events 2 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Viral infection	4.6% 7/151 • Number of events 7 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Injury, poisoning and procedural complications Accidental exposure	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/151 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Injury, poisoning and procedural complications Tongue injury	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Musculoskeletal and connective tissue disorders Synovitis	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Nervous system disorders Febrile convulsion	1.3% 2/151 • Number of events 3 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Reproductive system and breast disorders Penile swelling	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Asthma	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Skin and subcutaneous tissue disorders Urticaria	1.3% 2/151 • Number of events 3 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.

Measure	2-year Olds n=151 participants at risk Healthy children 2 years of age who had previously received IMBV at the recommended 12 and 13 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.	5-year Olds n=154 participants at risk Healthy children 5 years of age who had received IMBV at the recommended 12, 13, and 24 months of age received one dose of live, attenuated Japanese encephalitis SA 14-14-2 vaccine (LJEV) administered subcutaneously in the right upper arm on Study Day 0.
Ear and labyrinth disorders Ear pain	0.00% 0/151 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Eye disorders Conjunctivitis	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Eye disorders Eye swelling	0.00% 0/151 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Eye disorders Ocular hyperaemia	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Gastrointestinal disorders Abdominal pain	0.00% 0/151 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Gastrointestinal disorders Diarrhoea	2.0% 3/151 • Number of events 3 • 1 year for serious adverse events, 28 days for non-serious adverse events.	1.3% 2/154 • Number of events 2 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Gastrointestinal disorders Vomiting	1.3% 2/151 • Number of events 2 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
General disorders Pyrexia	10.6% 16/151 • Number of events 16 • 1 year for serious adverse events, 28 days for non-serious adverse events.	11.0% 17/154 • Number of events 17 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Bacterial infection	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Cellulitis	0.00% 0/151 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Enterobiasis	0.00% 0/151 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Gastritis viral	0.00% 0/151 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Gastroenteritis	1.3% 2/151 • Number of events 2 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Herpes zoster	0.00% 0/151 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Impetigo	0.00% 0/151 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Lower respiratory tract infection	3.3% 5/151 • Number of events 6 • 1 year for serious adverse events, 28 days for non-serious adverse events.	1.9% 3/154 • Number of events 3 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Nasopharyngitis	11.3% 17/151 • Number of events 17 • 1 year for serious adverse events, 28 days for non-serious adverse events.	7.1% 11/154 • Number of events 11 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Rash pustular	0.00% 0/151 • 1 year for serious adverse events, 28 days for non-serious adverse events.	2.6% 4/154 • Number of events 4 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Respiratory tract infection	0.00% 0/151 • 1 year for serious adverse events, 28 days for non-serious adverse events.	1.9% 3/154 • Number of events 3 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Rhinitis	0.00% 0/151 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Tonsillitis	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Upper respiratory tract infection	1.3% 2/151 • Number of events 2 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Urinary tract infection	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Infections and infestations Viral infection	4.6% 7/151 • Number of events 7 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Injury, poisoning and procedural complications Accidental exposure	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Injury, poisoning and procedural complications Cephalhaematoma	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Injury, poisoning and procedural complications Injury	0.00% 0/151 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Injury, poisoning and procedural complications Laceration	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/151 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Injury, poisoning and procedural complications Tongue injury	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Musculoskeletal and connective tissue disorders Synovitis	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Nervous system disorders Febrile convulsion	1.3% 2/151 • Number of events 2 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Reproductive system and breast disorders Penile swelling	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Asthma	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Cough	13.2% 20/151 • Number of events 20 • 1 year for serious adverse events, 28 days for non-serious adverse events.	13.0% 20/154 • Number of events 20 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/151 • 1 year for serious adverse events, 28 days for non-serious adverse events.	1.3% 2/154 • Number of events 2 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.3% 2/151 • Number of events 2 • 1 year for serious adverse events, 28 days for non-serious adverse events.	2.6% 4/154 • Number of events 4 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.00% 0/154 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Wheezing	2.6% 4/151 • Number of events 4 • 1 year for serious adverse events, 28 days for non-serious adverse events.	1.3% 2/154 • Number of events 2 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Skin and subcutaneous tissue disorders Blister	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/151 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Skin and subcutaneous tissue disorders Rash	0.00% 0/151 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/151 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Skin and subcutaneous tissue disorders Rash pruritic	0.66% 1/151 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
Skin and subcutaneous tissue disorders Urticaria	1.3% 2/151 • Number of events 2 • 1 year for serious adverse events, 28 days for non-serious adverse events.	0.65% 1/154 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.