Trial Outcomes & Findings for A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab (NCT NCT06042049)
NCT ID: NCT06042049
Last Updated: 2026-04-16
Results Overview
An AE was development of any untoward medical occurrence in a participant or clinical study participant administered medicinal product and which did not necessarily have causal relationship with this treatment. TEAEs were AEs whose onset occurred after receiving nirsevimab through 360 days post second dose. An SAE was any AE that resulted in death, was immediately life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly or birth defect or was an important medical event that might jeopardize the participant or may require medical treatment to prevent 1 of the outcomes listed above. AESIs were based on assessment by investigators following the administration of nirsevimab. An NOCD was a newly diagnosed medical condition of chronic, ongoing nature post administration of study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
33 participants
Primary outcome timeframe
From the first dose administration (Day 1) through 360 days post 2nd dose, study Day 511
Results posted on
2026-04-16
Participant Flow
This Phase III, single-arm, open-label study was conducted at 9 investigational sites in Japan in infants (\< or equal to 12 months of age at enrolment) with congenital heart disease, chronic lung disease, immunocompromise, down syndrome, or born pre-term.
The study had a screening visit (Day -30 to Day 1), study drug given in 2 doses (Day 1 and Day 150-180), and an end-of-study follow-up (360 days after the second or last dose). A total of 33 infants were enrolled. Final results are presented up to the last subject, last visit (LSLV) date of 24-Jul-2025.
Participant milestones
| Measure |
Nirsevimab 50 mg/100 mg
Participants in the first year of life received the first dose of nirsevimab on Day 1 as a single, fixed IM dose of 50 mg if body weight was \<5 kg or 100 mg if body weight was \>=5 kg. A second fixed IM dose of 50 mg was administered if body weight was \<5 kg or 100 mg if body weight was \>=5 kg at 5 to 6 months following the first dose (Day 150-180).
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
Received Study Dose 1
|
33
|
|
Overall Study
Received Study Dose 2
|
32
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two analysis population data are shown
Baseline characteristics by cohort
| Measure |
Nirsevimab 50 mg/100 mg
n=33 Participants
Participants in the first year of life received the first dose of nirsevimab on Day 1 as a single, fixed IM dose of 50 mg if body weight was \<5 kg or 100 mg if body weight was \>=5 kg. A second fixed IM dose of 50 mg was administered if body weight was \<5 kg or 100 mg if body weight was \>=5 kg at 5 to 6 months following the first dose (Day 150-180).
|
|---|---|
|
Age, Continuous
As-Treated Set 1
|
2.32 months
STANDARD_DEVIATION 2.39 • n=33 Participants • Two analysis population data are shown
|
|
Age, Continuous
As-Treated Set 2
|
2.32 months
STANDARD_DEVIATION 2.43 • n=32 Participants • Two analysis population data are shown
|
|
Sex: Female, Male
As-Treated Set 1 · Female
|
15 Participants
n=33 Participants • Two analysis population data are shown
|
|
Sex: Female, Male
As-Treated Set 1 · Male
|
18 Participants
n=33 Participants • Two analysis population data are shown
|
|
Sex: Female, Male
As-Treated Set 2 · Female
|
14 Participants
n=32 Participants • Two analysis population data are shown
|
|
Sex: Female, Male
As-Treated Set 2 · Male
|
18 Participants
n=32 Participants • Two analysis population data are shown
|
|
Race/Ethnicity, Customized
As-Treated Set 1 · Asian
|
33 Participants
n=33 Participants • Two analysis population data are shown
|
|
Race/Ethnicity, Customized
As-Treated Set 2 · Asian
|
32 Participants
n=32 Participants • Two analysis population data are shown
|
|
Ethnicity (NIH/OMB)
As-Treated Set 1 · Hispanic or Latino
|
0 Participants
n=33 Participants • Two analysis population data are shown
|
|
Ethnicity (NIH/OMB)
As-Treated Set 1 · Not Hispanic or Latino
|
33 Participants
n=33 Participants • Two analysis population data are shown
|
|
Ethnicity (NIH/OMB)
As-Treated Set 1 · Unknown or Not Reported
|
0 Participants
n=33 Participants • Two analysis population data are shown
|
|
Ethnicity (NIH/OMB)
As-Treated Set 2 · Hispanic or Latino
|
0 Participants
n=32 Participants • Two analysis population data are shown
|
|
Ethnicity (NIH/OMB)
As-Treated Set 2 · Not Hispanic or Latino
|
32 Participants
n=32 Participants • Two analysis population data are shown
|
|
Ethnicity (NIH/OMB)
As-Treated Set 2 · Unknown or Not Reported
|
0 Participants
n=32 Participants • Two analysis population data are shown
|
PRIMARY outcome
Timeframe: From the first dose administration (Day 1) through 360 days post 2nd dose, study Day 511Population: all participants who received the 2 doses of IMP
An AE was development of any untoward medical occurrence in a participant or clinical study participant administered medicinal product and which did not necessarily have causal relationship with this treatment. TEAEs were AEs whose onset occurred after receiving nirsevimab through 360 days post second dose. An SAE was any AE that resulted in death, was immediately life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly or birth defect or was an important medical event that might jeopardize the participant or may require medical treatment to prevent 1 of the outcomes listed above. AESIs were based on assessment by investigators following the administration of nirsevimab. An NOCD was a newly diagnosed medical condition of chronic, ongoing nature post administration of study drug.
Outcome measures
| Measure |
Nirsevimab 50 mg/100 mg
n=32 Participants
Participants in the first year of life received the first dose of nirsevimab on Day 1 as a single, fixed IM dose of 50 mg if body weight was \<5 kg or 100 mg if body weight was \>=5 kg. A second fixed IM dose of 50 mg was administered if body weight was \<5 kg or 100 mg if body weight was \>=5 kg at 5 to 6 months following the first dose (Day 150-180).
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), Adverse Events of Special Interest (AESIs), and New-onset Chronic Diseases (NOCDs)
TEAE
|
32 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), Adverse Events of Special Interest (AESIs), and New-onset Chronic Diseases (NOCDs)
TESAE
|
8 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), Adverse Events of Special Interest (AESIs), and New-onset Chronic Diseases (NOCDs)
AESI
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), Adverse Events of Special Interest (AESIs), and New-onset Chronic Diseases (NOCDs)
NOCD
|
1 Participants
|
SECONDARY outcome
Timeframe: Pre-dose Day 1, pre-dose Day 151, Day 181 post first-dose, Day 301 post first-dose, and Day 511 post first-dosePopulation: Participants who receive at least 1 dose of IMP and who have at least 1 quantifiable serum PK observations. Protocol deviations that impact the PK results may result in exclusion of the participant or data.
Serum samples were collected at specified timepoints to evaluate concentrations of nirsevimab at selected time points.
Outcome measures
| Measure |
Nirsevimab 50 mg/100 mg
n=33 Participants
Participants in the first year of life received the first dose of nirsevimab on Day 1 as a single, fixed IM dose of 50 mg if body weight was \<5 kg or 100 mg if body weight was \>=5 kg. A second fixed IM dose of 50 mg was administered if body weight was \<5 kg or 100 mg if body weight was \>=5 kg at 5 to 6 months following the first dose (Day 150-180).
|
|---|---|
|
Serum Concentrations of Nirsevimab
Pre-dose Day 1
|
0 microgram/milliliter (mcg/mL)
Geometric Coefficient of Variation 0
|
|
Serum Concentrations of Nirsevimab
Pre-dose Day 151
|
24.362 microgram/milliliter (mcg/mL)
Geometric Coefficient of Variation 24.639
|
|
Serum Concentrations of Nirsevimab
Day 181
|
129.554 microgram/milliliter (mcg/mL)
Geometric Coefficient of Variation 19.090
|
|
Serum Concentrations of Nirsevimab
Day 301
|
36.239 microgram/milliliter (mcg/mL)
Geometric Coefficient of Variation 48.154
|
|
Serum Concentrations of Nirsevimab
Day 511
|
3.234 microgram/milliliter (mcg/mL)
Geometric Coefficient of Variation 111.784
|
SECONDARY outcome
Timeframe: Pre-dose Day 1, pre-dose Day 151, Day 181 post first-dose, Day 301 post first-dose, and Day 511 post first-dosePopulation: Participants who received both doses of IMP and who have at least 1 non-missing (quantifiable or below LLOQ) ADA observation after the second dose. Protocol deviations that impact the ADA results may result in exclusion of the participant or data.
Blood samples were analyzed for the presence of ADAs for nirsevimab using an appropriately validated bioanalytical method.
Outcome measures
| Measure |
Nirsevimab 50 mg/100 mg
n=32 Participants
Participants in the first year of life received the first dose of nirsevimab on Day 1 as a single, fixed IM dose of 50 mg if body weight was \<5 kg or 100 mg if body weight was \>=5 kg. A second fixed IM dose of 50 mg was administered if body weight was \<5 kg or 100 mg if body weight was \>=5 kg at 5 to 6 months following the first dose (Day 150-180).
|
|---|---|
|
Number of Participants With Anti-drug Antibody (ADA) Response to Nirsevimab
Pre-dose Day 1
|
0 Participants
|
|
Number of Participants With Anti-drug Antibody (ADA) Response to Nirsevimab
Pre-dose Day 151
|
0 Participants
|
|
Number of Participants With Anti-drug Antibody (ADA) Response to Nirsevimab
Day 181
|
0 Participants
|
|
Number of Participants With Anti-drug Antibody (ADA) Response to Nirsevimab
Day 301
|
0 Participants
|
|
Number of Participants With Anti-drug Antibody (ADA) Response to Nirsevimab
Day 511
|
4 Participants
|
SECONDARY outcome
Timeframe: Pre-dose Day 1, pre-dose Day 151, Day 181 post first-dose, Day 301 post first-dose, and Day 511 post first-dosePopulation: Participants who received both doses of IMP and who have at least 1 quantifiable serum nAb observation(s) after the second dose. Protocol deviations that impact the nAb results may result in exclusion of the participant or data.
Blood samples were collected for the determination anti-RSV nAb in serum using an appropriately validated bioanalytical method.
Outcome measures
| Measure |
Nirsevimab 50 mg/100 mg
n=32 Participants
Participants in the first year of life received the first dose of nirsevimab on Day 1 as a single, fixed IM dose of 50 mg if body weight was \<5 kg or 100 mg if body weight was \>=5 kg. A second fixed IM dose of 50 mg was administered if body weight was \<5 kg or 100 mg if body weight was \>=5 kg at 5 to 6 months following the first dose (Day 150-180).
|
|---|---|
|
Serum Anti-respiratory Syncytial Virus (RSV) Neutralizing Antibody (nAb) Levels
Pre-dose Day 1
|
254.6 international units/mL
Geometric Coefficient of Variation 79.2
|
|
Serum Anti-respiratory Syncytial Virus (RSV) Neutralizing Antibody (nAb) Levels
Pre-dose Day 151
|
8127.4 international units/mL
Geometric Coefficient of Variation 18.8
|
|
Serum Anti-respiratory Syncytial Virus (RSV) Neutralizing Antibody (nAb) Levels
Day 181
|
28552.2 international units/mL
Geometric Coefficient of Variation 9.5
|
|
Serum Anti-respiratory Syncytial Virus (RSV) Neutralizing Antibody (nAb) Levels
Day 301
|
11241.0 international units/mL
Geometric Coefficient of Variation 24.8
|
|
Serum Anti-respiratory Syncytial Virus (RSV) Neutralizing Antibody (nAb) Levels
Day 511
|
1302.1 international units/mL
Geometric Coefficient of Variation 58.1
|
Adverse Events
Nirsevimab
Serious events: 8 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nirsevimab
n=32 participants at risk
50 mg/100 mg
|
|---|---|
|
Nervous system disorders
Infantile spasms
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Bronchitis
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Bronchitis viral
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Metapneumovirus pneumonia
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Pneumonia bacterial
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Viral sepsis
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Injury, poisoning and procedural complications
Thermal burn
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Gastroenteritis adenovirus
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
HCoV-OC43 infection
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
Other adverse events
| Measure |
Nirsevimab
n=32 participants at risk
50 mg/100 mg
|
|---|---|
|
Investigations
Neutrophil count decreased
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Cardiac disorders
Pulmonary valve stenosis
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Blood and lymphatic system disorders
Anaemia neonatal
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Nervous system disorders
Epilepsy
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Eye disorders
Eye pruritus
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
6.2%
2/32 • Number of events 2 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.4%
3/32 • Number of events 7 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.4%
3/32 • Number of events 3 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
9.4%
3/32 • Number of events 3 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
15.6%
5/32 • Number of events 5 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Pharyngitis
|
6.2%
2/32 • Number of events 2 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Respiratory syncytial virus infection
|
9.4%
3/32 • Number of events 3 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Rhinitis
|
15.6%
5/32 • Number of events 6 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Upper respiratory tract infection
|
78.1%
25/32 • Number of events 65 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Viral upper respiratory tract infection
|
31.2%
10/32 • Number of events 17 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Injury, poisoning and procedural complications
Chillblains
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
18.8%
6/32 • Number of events 13 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Injury, poisoning and procedural complications
Inflammation of wound
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Injury, poisoning and procedural complications
Post procedural oedema
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Injury, poisoning and procedural complications
Radial head dislocation
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Injury, poisoning and procedural complications
Scratch
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Injury, poisoning and procedural complications
Thermal burn
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Vascular disorders
Vascular insufficiency
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
General disorders
Injection site erythema
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
General disorders
Peripheral swelling
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
General disorders
Pyrexia
|
43.8%
14/32 • Number of events 17 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
General disorders
Vaccination site erythema
|
6.2%
2/32 • Number of events 2 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Immune system disorders
Food allergy
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Eye disorders
Conjunctivitis allergic
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Gastrointestinal disorders
Enteritis
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
12.5%
4/32 • Number of events 5 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Gastrointestinal disorders
Anal inflammation
|
6.2%
2/32 • Number of events 2 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Gastrointestinal disorders
Constipation
|
9.4%
3/32 • Number of events 3 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Gastrointestinal disorders
Diarrhoea
|
28.1%
9/32 • Number of events 13 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Gastrointestinal disorders
Vomiting
|
9.4%
3/32 • Number of events 5 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Renal and urinary disorders
Haematuria
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
3.1%
1/32 • Number of events 2 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
6.2%
2/32 • Number of events 2 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
12.5%
4/32 • Number of events 5 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
25.0%
8/32 • Number of events 13 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
2/32 • Number of events 5 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Skin and subcutaneous tissue disorders
Eczema
|
25.0%
8/32 • Number of events 8 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
6.2%
2/32 • Number of events 4 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Skin and subcutaneous tissue disorders
Eczema infantile
|
12.5%
4/32 • Number of events 4 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
9.4%
3/32 • Number of events 3 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.2%
2/32 • Number of events 2 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Metabolism and nutrition disorders
Failure to thrive
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Metabolism and nutrition disorders
Feeding disorder
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Abscess limb
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Adenoviral conjunctivitis
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Anal abscess
|
6.2%
2/32 • Number of events 2 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Bronchitis
|
12.5%
4/32 • Number of events 7 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Bronchitis viral
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Conjunctivitis
|
9.4%
3/32 • Number of events 4 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Conjunctivitis bacterial
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Exanthema subitum
|
12.5%
4/32 • Number of events 5 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Gastroenteritis
|
21.9%
7/32 • Number of events 7 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Gastroenteritis norovirus
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Gastroenteritis viral
|
6.2%
2/32 • Number of events 2 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
37.5%
12/32 • Number of events 14 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Hordeolum
|
9.4%
3/32 • Number of events 3 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Impetigo
|
6.2%
2/32 • Number of events 2 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Influenza
|
12.5%
4/32 • Number of events 4 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Lower respiratory tract infection
|
15.6%
5/32 • Number of events 13 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Lower respiratory tract infection viral
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Nasopharyngitis
|
28.1%
9/32 • Number of events 22 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Oral candidiasis
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Otitis externa
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Otitis externa bacterial
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Otitis media
|
12.5%
4/32 • Number of events 6 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Parainfluenzae viral bronchitis
|
6.2%
2/32 • Number of events 3 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Paronychia
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Skin and subcutaneous tissue disorders
Idiopathic urticaria
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Endocrine disorders
Hypothyroidism
|
6.2%
2/32 • Number of events 2 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
COVID-19
|
15.6%
5/32 • Number of events 5 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Dacryocystitis
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Norovirus infection
|
12.5%
4/32 • Number of events 4 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Sinusitis
|
6.2%
2/32 • Number of events 2 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Streptococcal infection
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Infections and infestations
Suspected COVID-19
|
6.2%
2/32 • Number of events 2 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
6.2%
2/32 • Number of events 2 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Immune system disorders
Allergy to animal
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
|
Immune system disorders
Bacille Calmette-Guerin scar reactivation
|
3.1%
1/32 • Number of events 1 • From 1st dose through 360 days after 2nd dose
Safety analyses and AE reporting is based on ATS2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place