Trial Outcomes & Findings for Post-licensure Safety Study of IMOJEV® in Thailand (NCT NCT01981967)
NCT ID: NCT01981967
Last Updated: 2016-05-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
10000 participants
Primary outcome timeframe
30 minutes post-vaccination up to Day 60 post-vaccination
Results posted on
2016-05-04
Participant Flow
The study participants were enrolled from 03 November 2013 to 08 February 2015 in 10 trial centers in Thailand.
A total of 10,000 participants who met all of the inclusion and none of the exclusion criteria were vaccinated in this study.
Participant milestones
| Measure |
Primary Vaccination Group
Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
|
Booster Vaccination Group
Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
|
|---|---|---|
|
Overall Study
STARTED
|
6851
|
3149
|
|
Overall Study
COMPLETED
|
6851
|
3149
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-licensure Safety Study of IMOJEV® in Thailand
Baseline characteristics by cohort
| Measure |
Primary Vaccination Group
n=6851 Participants
Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
|
Booster Vaccination Group
n=3149 Participants
Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
|
Total
n=10000 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6851 Participants
n=5 Participants
|
3149 Participants
n=7 Participants
|
10000 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
|
1.22 Years
STANDARD_DEVIATION 0.486 • n=5 Participants
|
3.60 Years
STANDARD_DEVIATION 0.892 • n=7 Participants
|
1.97 Years
STANDARD_DEVIATION 1.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3321 Participants
n=5 Participants
|
1550 Participants
n=7 Participants
|
4871 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3530 Participants
n=5 Participants
|
1599 Participants
n=7 Participants
|
5129 Participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
6851 Participants
n=5 Participants
|
3149 Participants
n=7 Participants
|
10000 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutes post-vaccination up to Day 60 post-vaccinationPopulation: Safety outcome were assessed in subjects who had received the study vaccine, the Safety Analysis Set
Outcome measures
| Measure |
Primary Vaccination Group
n=6851 Participants
Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
|
Booster Vaccination Group
n=3149 Participants
Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
|
|---|---|---|
|
Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV®
Grade 3 immediate systemic adverse event
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV®
Seriuos adverse events
|
204 Participants
|
59 Participants
|
|
Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV®
Death
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day O up to Day 60 post-vaccinationPopulation: Safety outcome were assessed in subjects who had received the study vaccine, the Safety Analysis Set
Outcome measures
| Measure |
Primary Vaccination Group
n=6851 Participants
Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
|
Booster Vaccination Group
n=3149 Participants
Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
|
|---|---|---|
|
Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV®
SAEs in Subjects 9 to <12 Months
|
43 Participants
|
0 Participants
|
|
Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV®
SAEs in Subjects 1 to 2 Years
|
155 Participants
|
0 Participants
|
|
Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV®
SAEs in Subjects 2 to <5 Years
|
6 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: Day O up to Day 60 post-vaccinationPopulation: Safety outcome were assessed in subjects who had received the study vaccine, the Safety Analysis Set
Adverse Events of Special Interest (AESIs) included hypersensitivity/allergic reactions, neurological events (including febrile convulsions), and vaccine failure.
Outcome measures
| Measure |
Primary Vaccination Group
n=6851 Participants
Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
|
Booster Vaccination Group
n=3149 Participants
Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
|
|---|---|---|
|
Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV®
Febrile convulsion
|
25 Participants
|
2 Participants
|
|
Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV®
Convulsion
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV®
Epilepsy
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV®
Frontal lobe epilepsy
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV®
Urticaria
|
0 Participants
|
2 Participants
|
Adverse Events
Primary Vaccination Group
Serious events: 204 serious events
Other events: 0 other events
Deaths: 0 deaths
Booster Vaccination Group
Serious events: 59 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Primary Vaccination Group
n=6851 participants at risk
Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
|
Booster Vaccination Group
n=3149 participants at risk
Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.12%
8/6851 • Number of events 8 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6851 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.03%
1/3149 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Gastrointestinal disorders
Enteritis
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/6851 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.03%
1/3149 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Gastrointestinal disorders
Gastritis
|
0.12%
8/6851 • Number of events 8 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.13%
4/3149 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
General disorders
Influenza like illness
|
0.00%
0/6851 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.03%
1/3149 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
General disorders
Pyrexia
|
0.00%
0/6851 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.03%
1/3149 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Immune system disorders
Allergy to arthropod sting
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Abscess limb
|
0.00%
0/6851 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.03%
1/3149 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Acute tonsillitis
|
0.06%
4/6851 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Anal abscess
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Bronchiolitis
|
0.09%
6/6851 • Number of events 6 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Bronchitis
|
0.25%
17/6851 • Number of events 17 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.32%
10/3149 • Number of events 10 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Bronchitis viral
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Burkholderia pseudomallei infection
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Cellulitis
|
0.03%
2/6851 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Croup infectious
|
0.03%
2/6851 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Dengue fever
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.03%
1/3149 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Diarrhoea infectious
|
0.07%
5/6851 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Exanthema subitum
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Gastritis bacterial
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Gastroenteritis
|
0.41%
28/6851 • Number of events 29 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.25%
8/3149 • Number of events 8 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.03%
2/6851 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Gastroenteritis viral
|
0.06%
4/6851 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Hand-foot-mouth disease
|
0.09%
6/6851 • Number of events 6 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.06%
2/3149 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Herpangina
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Infectious mononucleosis
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.06%
2/3149 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Influenza
|
0.06%
4/6851 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.16%
5/3149 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Laryngitis
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Nasopharyngitis
|
0.03%
2/6851 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.10%
3/3149 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6851 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.03%
1/3149 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Otitis media acute
|
0.04%
3/6851 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Pharyngitis
|
0.15%
10/6851 • Number of events 10 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Pharyngitis bacterial
|
0.03%
2/6851 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Pharyngotonsillitis
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Pneumonia
|
0.35%
24/6851 • Number of events 24 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.22%
7/3149 • Number of events 7 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Pneumonia bacterial
|
0.06%
4/6851 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.06%
4/6851 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Pneumonia viral
|
0.15%
10/6851 • Number of events 11 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.03%
1/3149 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Pyelonephritis
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.03%
1/3149 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6851 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.06%
2/3149 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Scarlet fever
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Scrotal abcess
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Sinusitis
|
0.03%
2/6851 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/6851 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.03%
1/3149 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Upper respiratory tract infection
|
0.06%
4/6851 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.03%
1/3149 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Urinary track infection
|
0.09%
6/6851 • Number of events 6 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Viral diarrhoea
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Viral infection
|
0.03%
2/6851 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Infections and infestations
Viral rash
|
0.03%
2/6851 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6851 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.03%
1/3149 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/6851 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.03%
1/3149 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Nervous system disorders
Convulsion
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Nervous system disorders
Epilepsy
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Nervous system disorders
Febrile convulsion
|
0.36%
25/6851 • Number of events 28 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.06%
2/3149 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Nervous system disorders
Frontal lobe epilepsy
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.03%
2/6851 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.03%
1/3149 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6851 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.03%
1/3149 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.03%
2/6851 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.06%
2/3149 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
|
Vascular disorders
Kawasaki's disease
|
0.01%
1/6851 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
0.00%
0/3149 • Adverse event data were collected from Day 0 (post-vaccination) up to 60 post-vaccination
|
Other adverse events
Adverse event data not reported
Additional Information
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