Trial Outcomes & Findings for Study of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) Compared to CD.JEVAX™ in Toddlers (NCT NCT01396512)

Last Updated: 2014-04-25

Results Overview

Immunogenicity assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). Seroconversion was defined as the percentage of participants who developed neutralizing antibody titers above 10 (1/dil) when seronegative at baseline (\<1/10) or who presented a ≥4-fold rise in their neutralizing antibody titers when seropositive (≥1/10) at baseline.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

274 participants

Primary outcome timeframe

Day 28 post-vaccination

Results posted on

2014-04-25

Participant Flow

The study participants were enrolled from 12 July 2011 to 28 September 2012 at 10 clinic centers in South Korea.

A total of 274 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.

Participant milestones

Participant milestones
Measure	IMOJEV™ Vaccine Group Participants age 12 to 24 months received one dose of IMOJEV™	CD.JEVAX™ Vaccine Group Participants age 12 to 24 months received one dose of CD.JEVAX™
Overall Study STARTED	137	137
Overall Study COMPLETED	137	136
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	IMOJEV™ Vaccine Group Participants age 12 to 24 months received one dose of IMOJEV™	CD.JEVAX™ Vaccine Group Participants age 12 to 24 months received one dose of CD.JEVAX™
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Study of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) Compared to CD.JEVAX™ in Toddlers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IMOJEV™ Vaccine Group n=137 Participants Participants age 12 to 24 months received one dose of IMOJEV™	CD.JEVAX™ Vaccine Group n=137 Participants Participants age 12 to 24 months received one dose of CD.JEVAX™	Total n=274 Participants Total of all reporting groups
Age, Categorical <=18 years	137 Participants n=5 Participants	137 Participants n=7 Participants	274 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	14.0 Months STANDARD_DEVIATION 2.0 • n=5 Participants	14.3 Months STANDARD_DEVIATION 2.2 • n=7 Participants	14.2 Months STANDARD_DEVIATION 2.1 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	57 Participants n=7 Participants	115 Participants n=5 Participants
Sex: Female, Male Male	79 Participants n=5 Participants	80 Participants n=7 Participants	159 Participants n=5 Participants
Region of Enrollment South Korea	137 Participants n=5 Participants	137 Participants n=7 Participants	274 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 28 post-vaccination

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

Outcome measures

Outcome measures
Measure	IMOJEV™ Vaccine Group n=119 Participants Participants age 12 to 24 months received one dose of IMOJEV™	CD.JEVAX™ Vaccine Group n=117 Participants Participants age 12 to 24 months received one dose of CD.JEVAX™
Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine	100 Percentage of Participants	99.1 Percentage of Participants

SECONDARY outcome

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

Population: Geometric mean titers against the JE-CV was assessed in the Per-Protocol Analysis Set.

Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). JE-CV PRNT50 antibody titer \>10 (1/dil, Day 0)

Outcome measures

Outcome measures
Measure	IMOJEV™ Vaccine Group n=119 Participants Participants age 12 to 24 months received one dose of IMOJEV™	CD.JEVAX™ Vaccine Group n=117 Participants Participants age 12 to 24 months received one dose of CD.JEVAX™
Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine JE-CV PRNT50 antibody titer (pre-vaccination)	5.0 Titers Interval 5.0 to 5.0	5.0 Titers Interval 5.0 to 5.0
Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine JE-CV PRNT50 antibody titer (post-vaccination)	908 Titers Interval 656.0 to 1256.0	579 Titers Interval 427.0 to 784.0

SECONDARY outcome

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

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

Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.

Outcome measures

Outcome measures
Measure	IMOJEV™ Vaccine Group n=119 Participants Participants age 12 to 24 months received one dose of IMOJEV™	CD.JEVAX™ Vaccine Group n=117 Participants Participants age 12 to 24 months received one dose of CD.JEVAX™
Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine JE-CV PRNT50 antibody titer ≥10 (1/dil, Day 28)	119 Participants	116 Participants Interval 0.0 to 0.0
Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine JE-CV PRNT50 antibody titer ≥10 (1/dil, Day 0)	0 Participants	0 Participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Day 0 up to Day 14 post-vaccination

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

Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling longest diameter ≥50 mm. Grade 3 systemic reactions: Fever \>39.5°C; Vomiting ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - \>3 hours; Drowsiness - sleeping most of the time or difficult to wake; Appetite Loss - refuses ≥3 feeds or most feeds; Irritability - inconsolable.

Outcome measures

Outcome measures
Measure	IMOJEV™ Vaccine Group n=137 Participants Participants age 12 to 24 months received one dose of IMOJEV™	CD.JEVAX™ Vaccine Group n=137 Participants Participants age 12 to 24 months received one dose of CD.JEVAX™
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine Grade 3 Injection site Pain (N = 137, 137)	0 Participants	1 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine Injection site Swelling (N = 137, 137)	6 Participants	10 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine Grade 3 Injection site Swelling (N = 137, 137)	0 Participants	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine Grade 3 Vomiting (N = 137, 137)	1 Participants	2 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine Crying Abnormal (N = 137, 137)	27 Participants	35 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine Grade 3 Crying Abnormal (N = 137, 137)	2 Participants	3 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine Appetite Loss (N = 137, 137)	38 Participants	40 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine Grade 3 Appetite Loss (N = 137, 137)	4 Participants	1 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine Irritability (N = 137, 137)	31 Participants	36 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine Grade 3 Irritability (N = 137, 137)	1 Participants	5 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine Injection site Pain (N = 137, 137)	35 Participants	38 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine Injection site Erythema (N = 137, 137)	23 Participants	33 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine Grade 3 Injection site Erythema (N = 137, 137)	0 Participants	0 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine Fever (N = 134, 136)	33 Participants	34 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine Grade 3 Fever (N = 134, 136)	1 Participants	1 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine Vomiting (N = 137, 137)	9 Participants	14 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine Drowsiness (N = 137, 137)	23 Participants	33 Participants Interval 0.0 to 0.0
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine Grade 3 Drowsiness (N = 137, 137)	0 Participants	1 Participants Interval 0.0 to 0.0

Adverse Events

IMOJEV™ Vaccine Group

Serious events: 17 serious events

Other events: 74 other events

Deaths: 0 deaths

CD.JEVAX™ Vaccine Group

Serious events: 18 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

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	IMOJEV™ Vaccine Group n=137 participants at risk Participants age 12 to 24 months received one dose of IMOJEV™	CD.JEVAX™ Vaccine Group n=137 participants at risk Participants age 12 to 24 months received one dose of CD.JEVAX™
Gastrointestinal disorders Intestinal obstruction	0.73% 1/137 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/137 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Gastrointestinal disorders Intussusception	0.73% 1/137 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/137 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Gastrointestinal disorders Stomatitis	0.00% 0/137 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.73% 1/137 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
General disorders Pyrexia	0.73% 1/137 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	1.5% 2/137 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Hepatobiliary disorders Hepatitis	0.00% 0/137 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.73% 1/137 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Bronchiolitis	0.73% 1/137 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.73% 1/137 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Bronchitis	1.5% 2/137 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.73% 1/137 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Croup infectious	0.00% 0/137 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.73% 1/137 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Gastroenteritis	0.73% 1/137 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	2.2% 3/137 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Hand foot and mouth disease	0.00% 0/137 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.73% 1/137 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Herpangina	0.73% 1/137 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/137 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Lymph node abscess	0.73% 1/137 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/137 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Meningitis aseptic	0.73% 1/137 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.00% 0/137 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Pharyngitis	1.5% 2/137 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.73% 1/137 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Pharyngotonsillitis	0.73% 1/137 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.73% 1/137 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Pneumonia	3.6% 5/137 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	2.2% 3/137 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Urinary tract infection	0.00% 0/137 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.73% 1/137 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Nervous system disorders Febrile convulsion	0.00% 0/137 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.73% 1/137 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Nervous system disorders Kawasaki's disease	1.5% 2/137 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	0.73% 1/137 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.

Measure	IMOJEV™ Vaccine Group n=137 participants at risk Participants age 12 to 24 months received one dose of IMOJEV™	CD.JEVAX™ Vaccine Group n=137 participants at risk Participants age 12 to 24 months received one dose of CD.JEVAX™
Gastrointestinal disorders Diarrhea	6.6% 9/137 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	2.2% 3/137 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
General disorders Pyrexia	5.8% 8/137 • Number of events 8 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	6.6% 9/137 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Bronchitis	6.6% 9/137 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	4.4% 6/137 • Number of events 7 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Gastroenteritis	2.9% 4/137 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	5.1% 7/137 • Number of events 8 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Nasopharyngitis	30.7% 42/137 • Number of events 54 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	27.7% 38/137 • Number of events 44 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Otitis media	4.4% 6/137 • Number of events 7 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	5.8% 8/137 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Infections and infestations Upper respiratory tract infection	8.0% 11/137 • Number of events 13 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	2.9% 4/137 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	3.6% 5/137 • Number of events 7 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	5.1% 7/137 • Number of events 8 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
General disorders Injection site Pain	25.5% 35/137 • Number of events 35 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	27.7% 38/137 • Number of events 38 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
General disorders Injection site Erythema	16.8% 23/137 • Number of events 23 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	24.1% 33/137 • Number of events 33 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
General disorders Injection site Swelling	4.4% 6/137 • Number of events 6 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	7.3% 10/137 • Number of events 10 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
General disorders Fever	24.6% 33/134 • Number of events 33 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	25.0% 34/136 • Number of events 34 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Gastrointestinal disorders Vomiting	6.6% 9/137 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	10.2% 14/137 • Number of events 14 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Psychiatric disorders Crying Abnormal	19.7% 27/137 • Number of events 27 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	25.5% 35/137 • Number of events 35 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Nervous system disorders Drowsiness	16.8% 23/137 • Number of events 23 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	24.1% 33/137 • Number of events 33 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Metabolism and nutrition disorders Appetite Loss	27.7% 38/137 • Number of events 38 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	29.2% 40/137 • Number of events 40 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Psychiatric disorders Irritability	22.6% 31/137 • Number of events 31 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.	26.3% 36/137 • Number of events 36 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.