Trial Outcomes & Findings for Study of a Single Primary Dose Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Healthy Subjects (NCT NCT02492165)

Last Updated: 2022-03-28

Results Overview

Solicited injection-site: ≤ 23 months age: Tenderness, Erythema, and Swelling. For ≥ 2 years age: Pain, Erythema, and Swelling. Solicited systemic reactions: ≤ 23 months age, Fever (temperature) Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability, For ≥ 2 years age, Fever (temperature) Headache, Malaise, and Myalgia. Grade 3: Tenderness, Cries when injected limb is moved; Pain, Incapacitating, unable to perform usual activities or Significant; prevents daily activity (≥ 12 years); Erythema and Swelling (≤23 months to 11 years), ≥50 mm or \>100 mm (≥ 12 years). Grade 3 Fever, \> 39.5°C (≤ 23 months) or ≥39.0°C (≥ 2 years); Vomiting, ≥ 6 episodes per 24 hours; Crying abnormal, \> 3 hours; Drowsiness, Sleeping most of the time; Appetite loss, Refuses ≥ 3 feeds / meals; Irritability, Inconsolable. Headache, Malaise, and Myalgia, Significant; prevents daily activity.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

250 participants

Primary outcome timeframe

Day 0 up to Day 14 post-vaccination

Results posted on

2022-03-28

Participant Flow

Study participants were enrolled from 27 June 2015 to 24 August 2015 at 1 clinic center in Vietnam.

A total of 250 participants who met all inclusion and no exclusion criteria were enrolled and vaccinated.

Participant milestones

Participant milestones
Measure	9 Months to 4 Years Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	5 to 11 Years Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	12 to 17 Years Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	18 to 60 Years Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Overall Study STARTED	100	60	60	30
Overall Study COMPLETED	100	59	60	30
Overall Study NOT COMPLETED	0	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	9 Months to 4 Years Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	5 to 11 Years Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	12 to 17 Years Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	18 to 60 Years Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Overall Study Withdrawal by Subject	0	1	0	0

Baseline Characteristics

Study of a Single Primary Dose Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Healthy Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	9 Months to 4 Years n=100 Participants Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	5 to 11 Years n=60 Participants Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	12 to 17 Years n=60 Participants Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	18 to 60 Years n=30 Participants Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	Total n=250 Participants Total of all reporting groups
Age, Categorical <=18 years	100 Participants n=5 Participants	60 Participants n=7 Participants	60 Participants n=5 Participants	0 Participants n=4 Participants	220 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	30 Participants n=4 Participants	30 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 Age Continuous	0.7 Years STANDARD_DEVIATION 0.6 • n=5 Participants	8.7 Years STANDARD_DEVIATION 1.5 • n=7 Participants	13.9 Years STANDARD_DEVIATION 1.4 • n=5 Participants	38.7 Years STANDARD_DEVIATION 10.0 • n=4 Participants	15.75 Years STANDARD_DEVIATION 3.375 • n=21 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	31 Participants n=7 Participants	42 Participants n=5 Participants	22 Participants n=4 Participants	141 Participants n=21 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	29 Participants n=7 Participants	18 Participants n=5 Participants	8 Participants n=4 Participants	109 Participants n=21 Participants
Region of Enrollment Vietnam	100 Participants n=5 Participants	60 Participants n=7 Participants	60 Participants n=5 Participants	30 Participants n=4 Participants	250 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 0 up to Day 14 post-vaccination

Population: Solicited injection site and solicited systemic reactions were assessed in the Safety Analysis Set.

Outcome measures

Outcome measures
Measure	9 Months to 4 Years n=100 Participants Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	5 to 11 Years n=60 Participants Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	12 to 17 Years n=60 Participants Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	18 to 60 Years n=30 Participants Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Injection-site Tenderness/Pain	35 Participants	8 Participants	11 Participants	8 Participants
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Grade 3 Injection-site Tenderness/Pain	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Injection-site Erythema	6 Participants	3 Participants	0 Participants	0 Participants
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Grade 3 Injection-site Erythema	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Injection-site Swelling	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Grade 3 Injection-site Swelling	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Fever	14 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Grade 3 Fever	2 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Vomiting	12 Participants	NA Participants Event was not solicited for this group	NA Participants Event was not solicited for this group	NA Participants Event was not solicited for this group
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Grade 3 Vomiting	0 Participants	NA Participants Event was not solicited for this group	NA Participants Event was not solicited for this group	NA Participants Event was not solicited for this group
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Crying abnormal	20 Participants	NA Participants Event was not solicited for this group	NA Participants Event was not solicited for this group	NA Participants Event was not solicited for this group
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Grade 3 Crying abnormal	0 Participants	NA Participants Event was not solicited for this group	NA Participants Event was not solicited for this group	NA Participants Event was not solicited for this group
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Drowsiness	12 Participants	NA Participants Event was not solicited for this group	NA Participants Event was not solicited for this group	NA Participants Event was not solicited for this group
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Grade 3 Drowsiness	0 Participants	NA Participants Event was not solicited for this group	NA Participants Event was not solicited for this group	NA Participants Event was not solicited for this group
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Appetite loss	38 Participants	NA Participants Event was not solicited for this group	NA Participants Event was not solicited for this group	NA Participants Event was not solicited for this group
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Grade 3 Appetite loss	1 Participants	NA Participants Event was not solicited for this group	NA Participants Event was not solicited for this group	NA Participants Event was not solicited for this group
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Irritability	21 Participants	NA Participants Event was not solicited for this group	NA Participants Event was not solicited for this group	NA Participants Event was not solicited for this group
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Grade 3 Irritability	0 Participants	NA Participants Event was not solicited for this group	NA Participants Event was not solicited for this group	NA Participants Event was not solicited for this group
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Headache	NA Participants Event was not solicited for this group	9 Participants	14 Participants	10 Participants
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Grade 3 Headache	NA Participants Event was not solicited for this group	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Malaise	1 Participants	8 Participants	16 Participants	9 Participants
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Grade 3 Malaise	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Myalgia	0 Participants	5 Participants	9 Participants	5 Participants
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Grade 3 Myalgia	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

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

Population: Seroprotection was assessed in the Per-Protocol Analysis Set.

Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroprotection was defined as antibody titer levels ≥10 (1/dil).

Outcome measures

Outcome measures
Measure	9 Months to 4 Years n=76 Participants Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	5 to 11 Years n=60 Participants Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	12 to 17 Years n=19 Participants Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	18 to 60 Years n=5 Participants Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Pre-vaccination (Day 0)	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Post-vaccination (Day 28)	97.4 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants

PRIMARY outcome

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

Population: Seroconversion was assessed in the Per-Protocol Analysis Set.

Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer \<10 (1/dil) and post-vaccination titer ≥10 (1/dil) or participants with pre vaccination titer ≥10 (1/dil) and a ≥4-fold increase from pre- to post-vaccination.

Outcome measures

Outcome measures
Measure	9 Months to 4 Years n=76 Participants Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	5 to 11 Years n=60 Participants Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	12 to 17 Years n=19 Participants Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	18 to 60 Years n=5 Participants Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Percentage of Participants With Japanese Encephalitis Seroconversion Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)	97.4 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants

PRIMARY outcome

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

Population: Geometric mean titers were assessed in the Per Protocol Analysis Set.

Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50).

Outcome measures

Outcome measures
Measure	9 Months to 4 Years n=76 Participants Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	5 to 11 Years n=34 Participants Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	12 to 17 Years n=19 Participants Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	18 to 60 Years n=5 Participants Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Pre-vaccination (Day 0)	5.00 Titers (1/dil) Interval 5.0 to 5.0	5.00 Titers (1/dil) Interval 5.0 to 5.0	5.00 Titers (1/dil) Interval 5.0 to 5.0	5.00 Titers (1/dil) Interval 5.0 to 5.0
Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Post-vaccination (Day 28)	277 Titers (1/dil) Interval 192.0 to 399.0	1738 Titers (1/dil) Interval 1055.0 to 2862.0	1481 Titers (1/dil) Interval 762.0 to 2878.0	970 Titers (1/dil) Interval 65.6 to 14352.0

Adverse Events

9 Months to 4 Years

Serious events: 1 serious events

Other events: 38 other events

Deaths: 0 deaths

5 to 11 Years

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

12 to 17 Years

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

18 to 60 Years

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	9 Months to 4 Years n=100 participants at risk Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	5 to 11 Years n=60 participants at risk Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	12 to 17 Years n=60 participants at risk Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	18 to 60 Years n=30 participants at risk Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Nervous system disorders Syncope	0.00% 0/100 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	0.00% 0/60 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	1.7% 1/60 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	0.00% 0/30 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.
Skin and subcutaneous tissue disorders Dermatitis	1.0% 1/100 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	0.00% 0/60 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	0.00% 0/60 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	0.00% 0/30 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.

Other adverse events

Other adverse events
Measure	9 Months to 4 Years n=100 participants at risk Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	5 to 11 Years n=60 participants at risk Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	12 to 17 Years n=60 participants at risk Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).	18 to 60 Years n=30 participants at risk Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Gastrointestinal disorders Diarrhea	5.0% 5/100 • Number of events 7 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	0.00% 0/60 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	0.00% 0/60 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	0.00% 0/30 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.
Respiratory, thoracic and mediastinal disorders Cough	7.0% 7/100 • Number of events 7 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	0.00% 0/60 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	0.00% 0/60 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	0.00% 0/30 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.
General disorders Injection site Tenderness/Pain	34.0% 34/100 • Number of events 34 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	13.3% 8/60 • Number of events 8 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	18.3% 11/60 • Number of events 11 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	26.7% 8/30 • Number of events 8 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.
General disorders Injection site Erythema	6.0% 6/100 • Number of events 6 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	5.0% 3/60 • Number of events 3 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	0.00% 0/60 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	0.00% 0/30 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.
General disorders Fever	14.0% 14/100 • Number of events 14 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	11.7% 7/60 • Number of events 7 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	3.3% 2/60 • Number of events 2 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	3.3% 1/30 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.
Gastrointestinal disorders Vomiting	12.0% 12/100 • Number of events 12 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	— 0/0 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	— 0/0 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	— 0/0 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.
Psychiatric disorders Crying abnormal	20.0% 20/100 • Number of events 20 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	— 0/0 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	— 0/0 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	— 0/0 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.
Nervous system disorders Drowsiness	12.0% 12/100 • Number of events 12 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	— 0/0 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	— 0/0 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	— 0/0 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.
Metabolism and nutrition disorders Appetite loss	38.0% 38/100 • Number of events 38 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	— 0/0 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	— 0/0 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	— 0/0 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.
Psychiatric disorders Irritability	21.0% 21/100 • Number of events 21 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	— 0/0 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	— 0/0 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	— 0/0 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.
Nervous system disorders Headache	0.00% 0/100 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	15.0% 9/60 • Number of events 9 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	23.3% 14/60 • Number of events 14 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	33.3% 10/30 • Number of events 10 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.
General disorders Malaise	0.00% 0/100 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	13.3% 8/60 • Number of events 8 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	26.7% 16/60 • Number of events 16 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	30.0% 9/30 • Number of events 9 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/100 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	8.3% 5/60 • Number of events 5 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	15.0% 9/60 • Number of events 9 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.	16.7% 5/30 • Number of events 5 • Adverse event data were collected from Day 0 up to Day 28 post vaccination.

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