A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY) (MELODY)

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ClinicalTrials.gov Identifier: NCT03979313

Recruitment Status : Completed

First Posted : June 7, 2019

Results First Posted : February 28, 2024

Last Update Posted : February 28, 2024

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Sponsor:

Information provided by (Responsible Party):

AstraZeneca

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition	Respiratory Syncytial Virus Infections
Interventions	Drug: MEDI8897 Drug: Placebo
Enrollment	3012

Participant Flow

Recruitment Details

First Subject In: 23-07-2019. Last Subject Last Visit: 21-03-2023. The study was planned to analyze data on the full enrolment of approximately 3000 infants. The impact of the COVID-19 pandemic on RSV circulation led to the decision to analyze the primary endpoint based on the first 1500 subjects enrolled (Primary Cohort). After the COVID-19 pandemic the study restarted. So the study comprised 2 cohorts: a Primary and a Safety for a total of 3319 screened subjects.

Pre-assignment Details

1626 screened subjects in Primary Cohort. 136 subjects did not start the study: 98 not meeting the I/E criteria, 6 lost to follow-up, 25 withdrew the informed consent, 7 for other reason.

Overall 3319 screened subjects. 307 did not start the study: 192 not meeting the I/E criteria, 11 lost to follow-up, 90 withdrew the informed consent, 14 for other reason.


Arm/Group Title	Placebo	Medi8897
Arm/Group Description	Single IM dose of 50 mg (if < 5 kg ...	Single IM dose of 50 mg (if < 5 kg ...
Arm/Group Description	Single IM dose of 50 mg (if < 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).	Single IM dose of 50 mg (if < 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
Period Title: Primary Cohort (Data Cut Off 11/3/2021)
Started	496	994
Completed Day 151 Follow up	488	977
Completed Day 361 Follow up	453	914
Treated Participants	491	994
Completed ^[1]	43	89
Not Completed	453	905
Reason Not Completed
Lost to Follow-up	3	9
Any Other Reason	3	4
Death	0	4
Withdrawal by Subject	14	20
Covid-19 pandemic	1	3
Ongoing at the DCO date	432	865
[1] Study completion at Day 511. At this DCO several subjects did not complete the study and were still ongoing.
Period Title: All Subjects
Started	1003	2009
Completed Day 151 Follow up	985	1977
Completed Day 361 Follow up	967	1944
Treated Participants	997	1997
Completed ^[1]	923	1873
Not Completed	80	136
Reason Not Completed
Any Other Reason	16	23
Covid-19	1	3
Withdrawal by Subject	35	44
Death	0	5
Lost to Follow-up	28	61
[1] Study completion at day 511

Baseline Characteristics

Arm/Group Title		Placebo	Medi8897	Total
Arm/Group Description		Single IM dose of 50 mg (if < 5 kg ...	Single IM dose of 50 mg (if < 5 kg ...	Total of all reporting groups
Arm/Group Description		Single IM dose of 50 mg (if < 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).	Single IM dose of 50 mg (if < 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).	Total of all reporting groups
Overall Number of Baseline Participants		1003	2009	3012
Baseline Analysis Population Description		...
Baseline Analysis Population Description		These are the Overall Number of All Subjects Population
Age, Continuous ^[1] Mean (Standard Deviation) Unit of measure: Months
Age (months) in Primary Cohort	Number Analyzed	496 participants	994 participants	1490 participants
Age (months) in Primary Cohort		3.012 (2.2520)	2.912 (2.2099)	2.946 (2.2237)
Age (months) in All Subjects	Number Analyzed	1003 participants	2009 participants	3012 participants
Age (months) in All Subjects		2.918 (2.2740)	2.905 (2.220)	2.909 (2.2376)
		[1] Measure Analysis Population Description: Two analysis population data are shown: Primary Cohort and All Subjects
Sex: Female, Male ^[1] Measure Type: Count of Participants Unit of measure: Participants
Sex in Primary Cohort	Number Analyzed	496 participants	994 participants	1490 participants
	Female	257 51.8%	464 46.7%	721 48.4%
	Male	239 48.2%	530 53.3%	769 51.6%
Sex in All Subjects	Number Analyzed	1003 participants	2009 participants	3012 participants
	Female	500 49.9%	938 46.7%	1438 47.7%
	Male	503 50.1%	1071 53.3%	1574 52.3%
		[1] Measure Analysis Population Description: Two analysis population data are shown: Primary Cohort and All Subjects
Race/Ethnicity, Customized ^[1] Measure Type: Count of Participants Unit of measure: Participants
Race in Primary Cohort	Number Analyzed	496 participants	994 participants	1490 participants
	American Indian or Alaska Native	26 5.2%	57 5.7%	83 5.6%
	Asian	18 3.6%	36 3.6%	54 3.6%
	Black or African American	136 27.4%	286 28.8%	422 28.3%
	Native Hawaiian or other Pacific Islander	5 1.0%	6 0.6%	11 0.7%
	White	272 54.8%	524 52.7%	796 53.4%
	Multiple categories checked	1 0.2%	12 1.2%	13 0.9%
	Other	38 7.7%	70 7.0%	108 7.2%
	Missing	0 0.0%	3 0.3%	3 0.2%
Race in All Subjects	Number Analyzed	1003 participants	2009 participants	3012 participants
	American Indian or Alaska Native	52 5.2%	92 4.6%	144 4.8%
	Asian	50 5.0%	109 5.4%	159 5.3%
	Black or African American	138 13.8%	299 14.9%	437 14.5%
	Native Hawaiian or other Pacific Islander	8 0.8%	15 0.7%	23 0.8%
	White	541 53.9%	1052 52.4%	1593 52.9%
	Multiple categories checked	8 0.8%	19 0.9%	27 0.9%
	Other	206 20.5%	420 20.9%	626 20.8%
	Missing	0 0.0%	3 0.1%	3 0.1%
		[1] Measure Analysis Population Description: Two analysis population data are shown; Primary Cohort and All Subjects 3 subjects in the Medi998 had missing value for Race

Outcome Measures

1.Primary Outcome


Title	Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort)
Description	Primary Endpoint Analysed on Primary Cohort Through 150 Days (N=1490 P...
Description	Primary Endpoint Analysed on Primary Cohort Through 150 Days (N=1490 Participants)
Time Frame	Through 150 Days Post Dose

Outcome Measure Data

Analysis Population Description

ITT population / Primary Cohort


Arm/Group Title	Placebo	Medi8897
Arm/Group Description:	Single IM dose of 50 mg (if < 5 kg ...	Single IM dose of 50 mg (if < 5 kg ...
Arm/Group Description:	Single IM dose of 50 mg (if < 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).	Single IM dose of 50 mg (if < 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
Overall Number of Participants Analyzed	496	994
Measure Type: Count of Participants Unit of Measure: Participants
Observed events through day 150 post dose	25 5.0%	12 1.2%
Subjects requiring imputation (Subjects without events and not followed through 150 days post dose)	6 1.2%	15 1.5%
Subjects without event through day 150 post dose	465 93.8%	967 97.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Medi8897
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Poisson Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Relative Risk Reduction (RRR)
	Estimated Value	74.53
	Confidence Interval	(2-Sided) 95% 49.63 to 87.12
	Estimation Comments	RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors [age at randomisation] as covariate) obtained after multiple imputation

2.Secondary Outcome


Title	Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort)
Description	Hospitalization Analysed on Primary Cohort Through 150 Days (N=1490 Pa...
Description	Hospitalization Analysed on Primary Cohort Through 150 Days (N=1490 Participants)
Time Frame	Through 150 Days Post Dose

Outcome Measure Data

Analysis Population Description

ITT population / Primary Cohort


Arm/Group Title	Placebo	Medi8897
Arm/Group Description:	Single IM dose of 50 mg (if < 5 kg ...	Single IM dose of 50 mg (if < 5 kg ...
Arm/Group Description:	Single IM dose of 50 mg (if < 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).	Single IM dose of 50 mg (if < 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
Overall Number of Participants Analyzed	496	994
Measure Type: Count of Participants Unit of Measure: Participants
Observed events through day 150 post dose	8 1.6%	6 0.6%
Subjects requiring imputation (subjects without events and not followed through 150 days post dose)	6 1.2%	15 1.5%
Subjects without event through day 150 post dose	482 97.2%	973 97.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Medi8897
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0708
	Comments	[Not Specified]
	Method	Poisson Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Relative Risk Reduction (RRR)
	Estimated Value	62.15
	Confidence Interval	(2-Sided) 95% -8.57 to 86.80
	Estimation Comments	RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors [age at randomisation] as covariate) obtained after multiple imputation

3.Secondary Outcome


Title	Summary of Serum Concentrations (ug/mL) of MEDI8897 by Group
Description	Number of Subjects with at Least one Assessment
Description	Number of Subjects with at Least one Assessment
Time Frame	By visit until day 360 post dose

Outcome Measure Data

Analysis Population Description

As Treated Population (1997 Participants Treated in MEDI8897 arm)/ All Subjects


Arm/Group Title		Medi8897, 50 mg	Medi8897, 100 mg
Arm/Group Description:		Subjects with Weight < 5 Kg	Subjects with Weight >= 5 Kg
Arm/Group Description:		Subjects with Weight < 5 Kg	Subjects with Weight >= 5 Kg
Overall Number of Participants Analyzed		799	1198
Geometric Mean (Geometric Coefficient of Variation) Unit of Measure: ug/mL
Day 7 Post Dose	Number Analyzed	40 participants	59 participants
Day 7 Post Dose		89.91 (39.3%)	164.03 (15.8%)
Day 14 Post Dose	Number Analyzed	264 participants	264 participants
Day 14 Post Dose		74.09 (124.9%)	105.05 (89.2%)
Day 30 Post Dose	Number Analyzed	470 participants	878 participants
Day 30 Post Dose		68.63 (58.6%)	100.54 (90.1%)
Day 150 Post Dose	Number Analyzed	618 participants	969 participants
Day 150 Post Dose		18.32 (63.1%)	27.73 (62.9%)
Day 360 Post Dose	Number Analyzed	659 participants	1001 participants
Day 360 Post Dose		1.75 (76.7%)	2.86 (85.7%)

4.Secondary Outcome


Title	Anti-drug Antibody Results by Visit (As Treated Population)
Description	Number of subjects with a positive result and a valid titer result at ...
Description	Number of subjects with a positive result and a valid titer result at the specific visit
Time Frame	From baseline to 360 day post dose visit

Outcome Measure Data

Analysis Population Description

As Treated Population / All Subjects


Arm/Group Title		Placebo	Medi8897
Arm/Group Description:		Single IM dose of 50 mg (if < 5 kg ...	Single IM dose of 50 mg (if < 5 kg ...
Arm/Group Description:		Single IM dose of 50 mg (if < 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).	Single IM dose of 50 mg (if < 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
Overall Number of Participants Analyzed		968	1926
Measure Type: Count of Participants Unit of Measure: Participants
Baseline	Number Analyzed	968 participants	1926 participants
Baseline		4 0.4%	4 0.2%
Day 30 Post Dose	Number Analyzed	705 participants	1370 participants
Day 30 Post Dose		2 0.3%	14 1.0%
Day 150 Post Dose	Number Analyzed	885 participants	1765 participants
Day 150 Post Dose		1 0.1%	21 1.2%
Day 360 Post Dose	Number Analyzed	862 participants	1778 participants
Day 360 Post Dose		10 1.2%	81 4.6%

5.Other Pre-specified Outcome


Title	Number of Participants With MA RSV LRTI Through 150 Days Post Dose (All Subjects)
Description	Primary Endpoint Analysed on All Subjects Through 150 Days (N=3012 par...
Description	Primary Endpoint Analysed on All Subjects Through 150 Days (N=3012 participants)
Time Frame	Through 150 Days Post Dose

Outcome Measure Data

Analysis Population Description

ITT population / All Subjects


Arm/Group Title	Placebo	Medi8897
Arm/Group Description:	Single IM dose of 50 mg (if < 5 kg ...	Single IM dose of 50 mg (if < 5 kg ...
Arm/Group Description:	Single IM dose of 50 mg (if < 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).	Single IM dose of 50 mg (if < 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
Overall Number of Participants Analyzed	1003	2009
Measure Type: Count of Participants Unit of Measure: Participants
Observed events through day 150 post dose	54 5.4%	24 1.2%
Subjects requiring imputation (Subjects without events and not followed through 150 days post dose)	17 1.7%	31 1.5%
Subjects without event through day 150 post dose	932 92.9%	1954 97.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Medi8897
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Poisson Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Relative Risk Reduction (RRR)
	Estimated Value	76.36
	Confidence Interval	(2-Sided) 95% 62.27 to 85.18
	Estimation Comments	RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors [age at randomisation] as covariate) obtained after multiple imputation

6.Other Pre-specified Outcome


Title	Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (All Subjects)
Description	Hospitalization Analysed on All Subjects Through 150 Days (N=3012 part...
Description	Hospitalization Analysed on All Subjects Through 150 Days (N=3012 participants)
Time Frame	Through 150 Days Post Dose

Outcome Measure Data

Analysis Population Description

ITT population / All Subjects


Arm/Group Title	Placebo	Medi8897
Arm/Group Description:	Single IM dose of 50 mg (if < 5 kg ...	Single IM dose of 50 mg (if < 5 kg ...
Arm/Group Description:	Single IM dose of 50 mg (if < 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).	Single IM dose of 50 mg (if < 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
Overall Number of Participants Analyzed	1003	2009
Measure Type: Count of Participants Unit of Measure: Participants
Observed events through day 150 post dose	20 2.0%	9 0.4%
Subjects requiring imputation (Subjects without events and not followed through 150 days post dose)	18 1.8%	31 1.5%
Subjects without event through day 150 post dose	965 96.2%	1969 98.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Medi8897
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0002
	Comments	[Not Specified]
	Method	Poisson Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Relative Risk Reduction (RRR)
	Estimated Value	76.84
	Confidence Interval	(2-Sided) 95% 49.36 to 89.41
	Estimation Comments	RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors [age at randomisation] as covariate) obtained after multiple imputation

7.Other Pre-specified Outcome


Title	Number of Participants With Disease From the 2nd RSV Season (All Subjects)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	From Day 361 to Day 510 Post Dose

Outcome Measure Data

Analysis Population Description

ITT population / All Subjects


Arm/Group Title	Placebo	Medi8897
Arm/Group Description:	Single IM dose of 50 mg (if < 5 kg ...	Single IM dose of 50 mg (if < 5 kg ...
Arm/Group Description:	Single IM dose of 50 mg (if < 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).	Single IM dose of 50 mg (if < 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
Overall Number of Participants Analyzed	967	1944
Measure Type: Count of Participants Unit of Measure: Participants
MA RSV LRTI (protocol defined)	10 1.0%	19 1.0%
MA RSV LRTI hospitalisation (protocol defined)	3 0.3%	3 0.2%

Adverse Events

Time Frame	All-Cause Mortality monitored/assessed up to 510 days post dose . Adverse Events monitored/assessed up to day 360 post dose.
Adverse Event Reporting Description	Treatment Emergent Adverse Events through 360 days post dose are reported for Placebo and Medi8897 arms. The data are for the Treated Participants (997 for Placebo and 1997 for Medi8897 arm).

Arm/Group Title	Placebo		MEDI8897
Arm/Group Description	Single IM dose of 50 mg (if < 5 kg ...		Single IM dose of 50 mg (if < 5 kg ...
Arm/Group Description	Single IM dose of 50 mg (if < 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).		Single IM dose of 50 mg (if < 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing).
All-Cause Mortality
	Placebo		MEDI8897
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/997 (0.00%)		5/1997 (0.25%)
Serious Adverse Events Serious Adverse Events
	Placebo		MEDI8897
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	83/997 (8.32%)		149/1997 (7.46%)
Blood and lymphatic system disorders
Hypochromic anaemia ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Congenital, familial and genetic disorders
Bronchogenic cyst ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Phenylketonuria ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Pyloric stenosis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Gastrointestinal disorders
Food poisoning ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Gastritis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Gastrooesophageal reflux disease ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Impaired gastric emptying ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Intestinal obstruction ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Vomiting ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Allergic colitis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Allergic gastroenteritis ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Colitis ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Constipation ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Diarrhoea ^† 1	0/997 (0.00%)	0	3/1997 (0.15%)	3
Enteritis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
General disorders
Death ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Fever neonatal ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Pyrexia ^† 1	1/997 (0.10%)	1	6/1997 (0.30%)	6
Hepatobiliary disorders
Cholelithiasis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Jaundice ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Immune system disorders
Milk allergy ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Infections and infestations
Abscess limb ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Abscess neck ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Abscess of external auditory meatus ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Adenoviral upper respiratory infection ^† 1	0/997 (0.00%)	0	3/1997 (0.15%)	3
Bacterial sepsis ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Botulism ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Bronchiolitis ^† 1	17/997 (1.71%)	18	27/1997 (1.35%)	28
Bronchitis ^† 1	4/997 (0.40%)	5	3/1997 (0.15%)	5
Bronchitis viral ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Covid-19 ^† 1	2/997 (0.20%)	2	3/1997 (0.15%)	5
Covid-19 pneumonia ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Cellulitis ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Conjunctivitis viral ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Enterovirus infection ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Escherichia pyelonephritis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Escherichia urinary tract infection ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Exanthema subitum ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Gastroenteritis ^† 1	5/997 (0.50%)	5	14/1997 (0.70%)	15
Gastroenteritis escherichia coli ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Gastroenteritis adenovirus ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Gastroenteritis clostridial ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Gastroenteritis norovirus ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Gastroenteritis rotavirus ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Gastroenteritis viral ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Hand-foot-and-mouth disease ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Impetigo ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Infection ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Laryngitis ^† 1	3/997 (0.30%)	3	3/1997 (0.15%)	3
Lower respiratory tract infection ^† 1	0/997 (0.00%)	0	6/1997 (0.30%)	7
Lower respiratory tract infection viral ^† 1	1/997 (0.10%)	1	3/1997 (0.15%)	3
Nasopharyngitis ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Otitis media ^† 1	2/997 (0.20%)	2	0/1997 (0.00%)	0
Otitis media acute ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Pertussis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Pharyngotonsillitis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Pneumonia ^† 1	5/997 (0.50%)	5	13/1997 (0.65%)	14
Pneumonia aspiration ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Pneumonia pneumococcal ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Pneumonia respiratory syncytial viral ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Pneumonia viral ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Pyelonephritis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Respiratory syncytial virus bronchiolitis ^† 1	10/997 (1.00%)	10	5/1997 (0.25%)	5
Respiratory syncytial virus bronchitis ^† 1	2/997 (0.20%)	2	1/1997 (0.05%)	1
Staphylococcal abscess ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Staphylococcal scalded skin syndrome ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Streptococcal sepsis ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Tonsillitis ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Tracheobronchitis ^† 1	2/997 (0.20%)	2	0/1997 (0.00%)	0
Upper respiratory tract infection ^† 1	2/997 (0.20%)	2	4/1997 (0.20%)	4
Urinary tract infection ^† 1	5/997 (0.50%)	5	7/1997 (0.35%)	7
Urosepsis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Viral infection ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Viral upper respiratory tract infection ^† 1	0/997 (0.00%)	0	4/1997 (0.20%)	4
Injury, poisoning and procedural complications
Accidental exposure to product by child ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Accidental overdose ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Burns third degree ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Concussion ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Fall ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Femur fracture ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Hand fracture ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Head injury ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Skull fractured base ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Thermal burn ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Metabolism and nutrition disorders
Dairy intolerance ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Decreased appetite ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Dehydration ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Failure to thrive ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Food refusal ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Hypoglycaemia ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Musculoskeletal and connective tissue disorders
Scoliosis ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Nervous system disorders
Facial paralysis ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Febrile convulsion ^† 1	0/997 (0.00%)	0	4/1997 (0.20%)	4
Hypotonia ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Idiopathic generalised epilepsy ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Seizure ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Subarachnoid haemorrhage ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Psychiatric disorders
Behavioural insomnia of childhood ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Sleep terror ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Staring ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Respiratory, thoracic and mediastinal disorders
Apnoea ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Aspiration ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Bronchial hyperreactivity ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Pneumonitis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Skin and subcutaneous tissue disorders
Petechiae ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Vascular disorders
Kawasaki's disease ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Shock ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
1 Term from vocabulary, MedDRA 25.1 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Placebo		MEDI8897
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	836/997 (83.85%)		1717/1997 (85.98%)
Blood and lymphatic system disorders
Neutropenia ^† 1	2/997 (0.20%)	2	2/1997 (0.10%)	2
Normochromic normocytic anaemia ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Thrombocytopenia ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Thrombocytosis ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Anaemia ^† 1	8/997 (0.80%)	8	13/1997 (0.65%)	13
Anaemia neonatal ^† 1	1/997 (0.10%)	1	3/1997 (0.15%)	3
Hypochromic anaemia ^† 1	7/997 (0.70%)	8	13/1997 (0.65%)	13
Iron deficiency anaemia ^† 1	8/997 (0.80%)	8	14/1997 (0.70%)	14
Leukocytosis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Lymphadenitis ^† 1	1/997 (0.10%)	1	3/1997 (0.15%)	3
Lymphadenopathy ^† 1	3/997 (0.30%)	3	7/1997 (0.35%)	7
Microcytic anaemia ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Cardiac disorders
Left ventricular hypertrophy ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Sinus tachycardia ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Supraventricular extrasystoles ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Tachycardia ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Congenital, familial and genetic disorders
Aorta hypoplasia ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Atrial septal defect ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Brachycephaly ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Bronchogenic cyst ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Buried penis syndrome ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Congenital anomaly ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Congenital nystagmus ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Congenital tongue anomaly ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Congenital torticollis ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Congenital vesicoureteric reflux ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Cryptorchism ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Dacryostenosis congenital ^† 1	3/997 (0.30%)	3	16/1997 (0.80%)	16
Dermoid cyst ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Developmental hip dysplasia ^† 1	4/997 (0.40%)	4	4/1997 (0.20%)	4
Hydrocele ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Klippel-feil syndrome ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Laryngomalacia ^† 1	0/997 (0.00%)	0	4/1997 (0.20%)	4
Macrocephaly ^† 1	2/997 (0.20%)	2	0/1997 (0.00%)	0
Mitochondrial encephalomyopathy ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Patent ductus arteriosus ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Phimosis ^† 1	0/997 (0.00%)	0	3/1997 (0.15%)	3
Plagiocephaly ^† 1	4/997 (0.40%)	4	11/1997 (0.55%)	11
Talipes ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Telangiectasia congenital ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Vascular malformation ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Ventricular septal defect ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Ear and labyrinth disorders
Cerumen impaction ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Deafness neurosensory ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Ear pain ^† 1	7/997 (0.70%)	8	12/1997 (0.60%)	14
Excessive cerumen production ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Middle ear effusion ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Motion sickness ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	3
Otorrhoea ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Tympanic membrane hyperaemia ^† 1	2/997 (0.20%)	2	0/1997 (0.00%)	0
Endocrine disorders
Hypothyroidism ^† 1	2/997 (0.20%)	2	0/1997 (0.00%)	0
Eye disorders
Astigmatism ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Blepharitis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Cataract subcapsular ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Conjunctival haemorrhage ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Conjunctival hyperaemia ^† 1	2/997 (0.20%)	2	0/1997 (0.00%)	0
Conjunctivitis allergic ^† 1	2/997 (0.20%)	2	6/1997 (0.30%)	6
Dacryostenosis acquired ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Erythema of eyelid ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Eye discharge ^† 1	2/997 (0.20%)	2	6/1997 (0.30%)	6
Eye swelling ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Eyelid oedema ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Hypermetropia ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Keratitis ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Lacrimal structural disorder ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Lacrimation increased ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Ocular hyperaemia ^† 1	0/997 (0.00%)	0	4/1997 (0.20%)	4
Periorbital oedema ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Pseudostrabismus ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Pterygium ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Pupillary disorder ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Strabismus ^† 1	2/997 (0.20%)	2	3/1997 (0.15%)	3
Swelling of eyelid ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Gastrointestinal disorders
Faeces soft ^† 1	2/997 (0.20%)	2	3/1997 (0.15%)	3
Flatulence ^† 1	4/997 (0.40%)	4	13/1997 (0.65%)	13
Food protein-induced enterocolitis syndrome ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Gastritis ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Gastritis erosive ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Gastrooesophageal reflux disease ^† 1	14/997 (1.40%)	14	31/1997 (1.55%)	32
Gingival cyst ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Gingival discomfort ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Gingival pain ^† 1	1/997 (0.10%)	3	0/1997 (0.00%)	0
Haematemesis ^† 1	0/997 (0.00%)	0	3/1997 (0.15%)	3
Haematochezia ^† 1	5/997 (0.50%)	6	2/1997 (0.10%)	2
Infant dyschezia ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Infantile colic ^† 1	11/997 (1.10%)	13	41/1997 (2.05%)	41
Infantile spitting up ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Inguinal hernia ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Lip ulceration ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Melaena ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Mouth ulceration ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Mucous stools ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Oesophageal perforation ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Oral mucosal eruption ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Regurgitation ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Stomatitis ^† 1	4/997 (0.40%)	4	7/1997 (0.35%)	7
Teething ^† 1	70/997 (7.02%)	85	138/1997 (6.91%)	171
Toothache ^† 1	1/997 (0.10%)	1	6/1997 (0.30%)	12
Umbilical hernia ^† 1	4/997 (0.40%)	4	14/1997 (0.70%)	14
Vomiting ^† 1	32/997 (3.21%)	35	59/1997 (2.95%)	63
Abdominal distension ^† 1	0/997 (0.00%)	0	5/1997 (0.25%)	5
Abdominal mass ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Abdominal pain ^† 1	3/997 (0.30%)	3	2/1997 (0.10%)	2
Abdominal pain upper ^† 1	2/997 (0.20%)	2	3/1997 (0.15%)	3
Abdominal tenderness ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Aerophagia ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Anal fissure ^† 1	3/997 (0.30%)	3	6/1997 (0.30%)	6
Anal polyp ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Angular cheilitis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Aphthous ulcer ^† 1	2/997 (0.20%)	2	2/1997 (0.10%)	2
Auriculotemporal syndrome ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Cheilitis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Constipation ^† 1	38/997 (3.81%)	42	88/1997 (4.41%)	96
Diarrhoea ^† 1	89/997 (8.93%)	104	171/1997 (8.56%)	196
Dyspepsia ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Enteritis ^† 1	0/997 (0.00%)	0	3/1997 (0.15%)	3
Enterocolitis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Epulis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Faecaloma ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Faeces discoloured ^† 1	2/997 (0.20%)	2	1/1997 (0.05%)	1
General disorders
Asthenia ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Crying ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Developmental delay ^† 1	0/997 (0.00%)	0	3/1997 (0.15%)	3
Discomfort ^† 1	2/997 (0.20%)	2	10/1997 (0.50%)	10
Fatigue ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Gait disturbance ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Hypothermia ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Influenza like illness ^† 1	4/997 (0.40%)	4	2/1997 (0.10%)	2
Injection site induration ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Injection site pain ^† 1	0/997 (0.00%)	0	4/1997 (0.20%)	4
Injection site swelling ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Malaise ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Mass ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Pfapa syndrome ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Pain ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Peripheral swelling ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Pyrexia ^† 1	122/997 (12.24%)	165	290/1997 (14.52%)	378
Secretion discharge ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Vaccination site erythema ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Vaccination site pain ^† 1	1/997 (0.10%)	1	3/1997 (0.15%)	5
Vaccination site reaction ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Vaccination site swelling ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Vessel puncture site haemorrhage ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Xerosis ^† 1	1/997 (0.10%)	1	5/1997 (0.25%)	6
Hepatobiliary disorders
Hyperbilirubinaemia ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Jaundice ^† 1	1/997 (0.10%)	1	7/1997 (0.35%)	7
Immune system disorders
Allergy to animal ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Allergy to arthropod bite ^† 1	1/997 (0.10%)	1	6/1997 (0.30%)	6
Anaphylactic reaction ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Drug hypersensitivity ^† 1	3/997 (0.30%)	3	9/1997 (0.45%)	9
Dust allergy ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Food allergy ^† 1	18/997 (1.81%)	22	30/1997 (1.50%)	36
Hypersensitivity ^† 1	2/997 (0.20%)	2	1/1997 (0.05%)	1
Milk allergy ^† 1	4/997 (0.40%)	7	7/1997 (0.35%)	7
Multiple allergies ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Reaction to preservatives ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Seasonal allergy ^† 1	6/997 (0.60%)	6	8/1997 (0.40%)	8
Infections and infestations
Abscess ^† 1	2/997 (0.20%)	2	2/1997 (0.10%)	2
Abscess jaw ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Abscess limb ^† 1	3/997 (0.30%)	3	2/1997 (0.10%)	2
Abscess neck ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Acarodermatitis ^† 1	15/997 (1.50%)	20	32/1997 (1.60%)	39
Acute sinusitis ^† 1	3/997 (0.30%)	3	2/1997 (0.10%)	2
Adenoviral upper respiratory infection ^† 1	0/997 (0.00%)	0	6/1997 (0.30%)	6
Adenovirus infection ^† 1	3/997 (0.30%)	3	1/1997 (0.05%)	1
Amoebiasis ^† 1	0/997 (0.00%)	0	3/1997 (0.15%)	3
Amoebic dysentery ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Anal abscess ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Ascariasis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Asymptomatic covid-19 ^† 1	7/997 (0.70%)	8	8/1997 (0.40%)	8
Bacterial disease carrier ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Body tinea ^† 1	12/997 (1.20%)	14	20/1997 (1.00%)	22
Borrelia infection ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Bronchiolitis ^† 1	71/997 (7.12%)	86	119/1997 (5.96%)	139
Bronchitis ^† 1	31/997 (3.11%)	34	60/1997 (3.00%)	76
Bronchitis viral ^† 1	2/997 (0.20%)	3	1/1997 (0.05%)	1
Bullous impetigo ^† 1	1/997 (0.10%)	1	5/1997 (0.25%)	5
Covid-19 ^† 1	59/997 (5.92%)	62	97/1997 (4.86%)	98
Candida infection ^† 1	5/997 (0.50%)	5	4/1997 (0.20%)	5
Candida nappy rash ^† 1	3/997 (0.30%)	3	19/1997 (0.95%)	19
Cellulitis ^† 1	3/997 (0.30%)	3	6/1997 (0.30%)	6
Citrobacter infection ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Conjunctivitis ^† 1	56/997 (5.62%)	61	137/1997 (6.86%)	157
Conjunctivitis bacterial ^† 1	2/997 (0.20%)	3	6/1997 (0.30%)	6
Conjunctivitis viral ^† 1	0/997 (0.00%)	0	3/1997 (0.15%)	3
Croup infectious ^† 1	7/997 (0.70%)	7	17/1997 (0.85%)	18
Cystitis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Dacryocanaliculitis ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Dacryocystitis ^† 1	3/997 (0.30%)	3	2/1997 (0.10%)	2
Dermatitis infected ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Dermatophytosis ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Diarrhoea infectious ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Dysentery ^† 1	2/997 (0.20%)	2	1/1997 (0.05%)	1
Ear infection ^† 1	4/997 (0.40%)	5	4/1997 (0.20%)	4
Ear infection bacterial ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Ear lobe infection ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Eczema infected ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Enterobiasis ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Enterovirus infection ^† 1	1/997 (0.10%)	1	4/1997 (0.20%)	5
Exanthema subitum ^† 1	27/997 (2.71%)	27	30/1997 (1.50%)	30
Eye infection ^† 1	1/997 (0.10%)	1	7/1997 (0.35%)	9
Febrile infection ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Folliculitis ^† 1	4/997 (0.40%)	4	14/1997 (0.70%)	15
Fungal infection ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Fungal skin infection ^† 1	19/997 (1.91%)	19	35/1997 (1.75%)	37
Furuncle ^† 1	1/997 (0.10%)	1	3/1997 (0.15%)	3
Gastroenteritis ^† 1	100/997 (10.03%)	113	202/1997 (10.12%)	246
Gastroenteritis adenovirus ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Gastroenteritis bacterial ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Gastroenteritis enteroviral ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Gastroenteritis rotavirus ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Gastroenteritis viral ^† 1	8/997 (0.80%)	11	21/1997 (1.05%)	23
Gastrointestinal infection ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	2
Gastrointestinal viral infection ^† 1	0/997 (0.00%)	0	3/1997 (0.15%)	3
Genital candidiasis ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Genital infection fungal ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Gianotti-crosti syndrome ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Hand-foot-and-mouth disease ^† 1	19/997 (1.91%)	19	42/1997 (2.10%)	43
Helminthic infection ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Herpangina ^† 1	3/997 (0.30%)	3	5/1997 (0.25%)	5
Herpes ophthalmic ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Hordeolum ^† 1	2/997 (0.20%)	2	5/1997 (0.25%)	5
Human herpesvirus 6 infection ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Impetigo ^† 1	31/997 (3.11%)	35	43/1997 (2.15%)	47
Infected bite ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Infected dermal cyst ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Infected skin ulcer ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Infection ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Influenza ^† 1	1/997 (0.10%)	1	9/1997 (0.45%)	10
Joint abscess ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Laryngitis ^† 1	9/997 (0.90%)	9	35/1997 (1.75%)	37
Lice infestation ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Lower respiratory tract infection ^† 1	34/997 (3.41%)	44	47/1997 (2.35%)	69
Lower respiratory tract infection viral ^† 1	12/997 (1.20%)	12	9/1997 (0.45%)	9
Lyme disease ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Measles ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Mediastinitis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Meningitis aseptic ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Metapneumovirus infection ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Molluscum contagiosum ^† 1	1/997 (0.10%)	1	9/1997 (0.45%)	10
Nasopharyngitis ^† 1	237/997 (23.77%)	471	441/1997 (22.08%)	946
Omphalitis ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Oral candidiasis ^† 1	22/997 (2.21%)	23	55/1997 (2.75%)	60
Oral fungal infection ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Oral herpes ^† 1	1/997 (0.10%)	1	4/1997 (0.20%)	4
Oral infection ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Otitis externa ^† 1	6/997 (0.60%)	6	6/1997 (0.30%)	6
Otitis media ^† 1	76/997 (7.62%)	111	154/1997 (7.71%)	218
Otitis media acute ^† 1	44/997 (4.41%)	53	82/1997 (4.11%)	126
Otitis media chronic ^† 1	1/997 (0.10%)	2	2/1997 (0.10%)	2
Parasitic gastroenteritis ^† 1	2/997 (0.20%)	2	4/1997 (0.20%)	4
Paronychia ^† 1	2/997 (0.20%)	2	11/1997 (0.55%)	12
Periorbital cellulitis ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Pertussis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Pharyngitis ^† 1	28/997 (2.81%)	28	72/1997 (3.61%)	80
Pharyngitis streptococcal ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Pharyngotonsillitis ^† 1	9/997 (0.90%)	9	16/1997 (0.80%)	16
Pneumonia ^† 1	6/997 (0.60%)	6	11/1997 (0.55%)	11
Pneumonia bacterial ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Pneumonia moraxella ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Pulmonary tuberculosis ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Pustule ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Pyelonephritis ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Pyoderma ^† 1	1/997 (0.10%)	1	3/1997 (0.15%)	3
Pyoderma streptococcal ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Rash pustular ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Respiratory syncytial virus bronchiolitis ^† 1	14/997 (1.40%)	14	13/1997 (0.65%)	13
Respiratory syncytial virus bronchitis ^† 1	3/997 (0.30%)	3	0/1997 (0.00%)	0
Respiratory syncytial virus infection ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Respiratory tract infection ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Respiratory tract infection viral ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Rhinitis ^† 1	102/997 (10.23%)	146	201/1997 (10.07%)	272
Rhinolaryngitis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Roseola ^† 1	14/997 (1.40%)	14	24/1997 (1.20%)	24
Scarlet fever ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Sinusitis ^† 1	7/997 (0.70%)	7	9/1997 (0.45%)	9
Sinusitis bacterial ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Skin bacterial infection ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Skin candida ^† 1	3/997 (0.30%)	3	9/1997 (0.45%)	9
Skin infection ^† 1	2/997 (0.20%)	3	2/1997 (0.10%)	2
Subcutaneous abscess ^† 1	3/997 (0.30%)	3	2/1997 (0.10%)	2
Subglottic laryngitis ^† 1	2/997 (0.20%)	3	1/1997 (0.05%)	1
Suspected covid-19 ^† 1	7/997 (0.70%)	7	10/1997 (0.50%)	10
Tinea capitis ^† 1	3/997 (0.30%)	3	1/1997 (0.05%)	1
Tinea cruris ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Tinea infection ^† 1	0/997 (0.00%)	0	4/1997 (0.20%)	4
Tinea pedis ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Tinea versicolour ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Tonsillitis ^† 1	7/997 (0.70%)	7	14/1997 (0.70%)	15
Tracheitis ^† 1	2/997 (0.20%)	2	4/1997 (0.20%)	4
Tracheobronchitis ^† 1	3/997 (0.30%)	3	2/1997 (0.10%)	2
Upper respiratory tract infection ^† 1	316/997 (31.70%)	621	639/1997 (32.00%)	1316
Urinary tract infection ^† 1	14/997 (1.40%)	15	22/1997 (1.10%)	26
Urinary tract infection bacterial ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Vaccination site infection ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Varicella ^† 1	10/997 (1.00%)	10	22/1997 (1.10%)	22
Varicella zoster virus infection ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Viral diarrhoea ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Viral infection ^† 1	21/997 (2.11%)	22	35/1997 (1.75%)	36
Viral pharyngitis ^† 1	2/997 (0.20%)	2	9/1997 (0.45%)	9
Viral rash ^† 1	30/997 (3.01%)	32	85/1997 (4.26%)	90
Viral rhinitis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Viral tonsillitis ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Viral upper respiratory tract infection ^† 1	60/997 (6.02%)	77	132/1997 (6.61%)	162
Wound infection ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Injury, poisoning and procedural complications
Animal bite ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Animal scratch ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Arthropod bite ^† 1	22/997 (2.21%)	24	27/1997 (1.35%)	31
Arthropod sting ^† 1	2/997 (0.20%)	2	2/1997 (0.10%)	2
Bone contusion ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Brain contusion ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Burns first degree ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Burns second degree ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Chemical burn ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Concussion ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Contusion ^† 1	3/997 (0.30%)	3	11/1997 (0.55%)	11
Corneal abrasion ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Craniocerebral injury ^† 1	2/997 (0.20%)	2	6/1997 (0.30%)	6
Exposure to toxic agent ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Eye contusion ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Eye injury ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Eyelid injury ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Face injury ^† 1	2/997 (0.20%)	2	3/1997 (0.15%)	3
Fall ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Femur fracture ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Foreign body in ear ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Foreign body in eye ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Foreign body in gastrointestinal tract ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Foreign body in respiratory tract ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Foreign body in throat ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Foreign body ingestion ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Gingival injury ^† 1	1/997 (0.10%)	1	4/1997 (0.20%)	4
Hand fracture ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Head injury ^† 1	6/997 (0.60%)	7	16/1997 (0.80%)	17
Injury ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	2
Limb injury ^† 1	3/997 (0.30%)	3	3/1997 (0.15%)	3
Lip injury ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Mouth injury ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Multiple injuries ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Muscle contusion ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Nail injury ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Nasal injury ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Oral contusion ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Post procedural erythema ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Post procedural haemorrhage ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Post-traumatic pain ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Postoperative ileus ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Procedural pain ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Radial head dislocation ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Road traffic accident ^† 1	0/997 (0.00%)	0	3/1997 (0.15%)	3
Scratch ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Skin abrasion ^† 1	3/997 (0.30%)	3	8/1997 (0.40%)	8
Skin injury ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Skin laceration ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Skull fracture ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Thermal burn ^† 1	5/997 (0.50%)	5	9/1997 (0.45%)	10
Tibia fracture ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Tooth fracture ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Tooth injury ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Traumatic haematoma ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Vaccination complication ^† 1	34/997 (3.41%)	47	72/1997 (3.61%)	90
Vulvovaginal injury ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Investigations
Alanine aminotransferase increased ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Aspartate aminotransferase increased ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Blood copper increased ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Blood immunoglobulin e increased ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Blood lead increased ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Body temperature increased ^† 1	0/997 (0.00%)	0	5/1997 (0.25%)	5
Cardiac murmur ^† 1	4/997 (0.40%)	4	5/1997 (0.25%)	5
Cardiac murmur functional ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Echocardiogram abnormal ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Haemoglobin decreased ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Liver function test abnormal ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Medical observation normal ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Neutrophil count decreased ^† 1	2/997 (0.20%)	2	0/1997 (0.00%)	0
Platelet count increased ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Sars-cov-2 test negative ^† 1	27/997 (2.71%)	30	48/1997 (2.40%)	58
Sars-cov-2 test positive ^† 1	4/997 (0.40%)	4	3/1997 (0.15%)	3
Transaminases increased ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Urine analysis abnormal ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Metabolism and nutrition disorders
Abnormal weight gain ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Breast milk substitute intolerance ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Dairy intolerance ^† 1	3/997 (0.30%)	3	4/1997 (0.20%)	4
Decreased appetite ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Dehydration ^† 1	5/997 (0.50%)	5	2/1997 (0.10%)	2
Failure to thrive ^† 1	3/997 (0.30%)	3	6/1997 (0.30%)	6
Hyperglycaemia ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Hypoglycaemia ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Iron deficiency ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Lactose intolerance ^† 1	0/997 (0.00%)	0	4/1997 (0.20%)	4
Malnutrition ^† 1	0/997 (0.00%)	0	5/1997 (0.25%)	5
Poor feeding infant ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Underweight ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Vitamin b12 deficiency ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Vitamin d deficiency ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Weight gain poor ^† 1	5/997 (0.50%)	5	7/1997 (0.35%)	7
Musculoskeletal and connective tissue disorders
Acquired plagiocephaly ^† 1	3/997 (0.30%)	3	3/1997 (0.15%)	3
Arthropathy ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Diastasis recti abdominis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Foot deformity ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Growth retardation ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Haematoma muscle ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Head deformity ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Limb discomfort ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Musculoskeletal pain ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Posture abnormal ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Rib deformity ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Scoliosis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Torticollis ^† 1	1/997 (0.10%)	1	3/1997 (0.15%)	3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cartilage neoplasm ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Haemangioma ^† 1	1/997 (0.10%)	2	9/1997 (0.45%)	9
Haemangioma of skin ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Lipoma ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Melanocytic naevus ^† 1	0/997 (0.00%)	0	3/1997 (0.15%)	3
Pyogenic granuloma ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Skin papilloma ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Nervous system disorders
Chorea ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Febrile convulsion ^† 1	5/997 (0.50%)	5	4/1997 (0.20%)	4
Gross motor delay ^† 1	1/997 (0.10%)	1	3/1997 (0.15%)	3
Head discomfort ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Horner's syndrome ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Hypertonia ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Hypotonia ^† 1	2/997 (0.20%)	2	1/1997 (0.05%)	1
Idiopathic partial epilepsy ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Infant irritability ^† 1	4/997 (0.40%)	4	1/1997 (0.05%)	1
Motor developmental delay ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Nystagmus ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Post-traumatic epilepsy ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Psychomotor skills impaired ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Seizure ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Seizure like phenomena ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Somnolence ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Speech disorder developmental ^† 1	0/997 (0.00%)	0	3/1997 (0.15%)	3
Tremor ^† 1	0/997 (0.00%)	0	3/1997 (0.15%)	3
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Small for dates baby ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Umbilical granuloma ^† 1	3/997 (0.30%)	3	1/1997 (0.05%)	1
Psychiatric disorders
Anxiety ^† 1	2/997 (0.20%)	2	3/1997 (0.15%)	3
Irritability ^† 1	11/997 (1.10%)	11	22/1997 (1.10%)	26
Poor quality sleep ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Restlessness ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Sleep disorder ^† 1	1/997 (0.10%)	1	3/1997 (0.15%)	3
Renal and urinary disorders
Dysuria ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Haematuria ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Vesicoureteric reflux ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Reproductive system and breast disorders
Acquired hydrocele ^† 1	0/997 (0.00%)	0	3/1997 (0.15%)	3
Balanoposthitis ^† 1	2/997 (0.20%)	2	6/1997 (0.30%)	6
Breast cyst ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Breast enlargement ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Genital discomfort ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Genital labial adhesions ^† 1	2/997 (0.20%)	2	3/1997 (0.15%)	3
Genital pain ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Genital ulceration ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Penile adhesion ^† 1	5/997 (0.50%)	5	6/1997 (0.30%)	6
Penile discharge ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Penile erythema ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Testicular mass ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Vaginal discharge ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Vulvovaginal adhesion ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Vulvovaginal erythema ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Aphonia ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Asthma ^† 1	1/997 (0.10%)	1	4/1997 (0.20%)	6
Brief resolved unexplained event ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Bronchial hyperreactivity ^† 1	3/997 (0.30%)	3	3/1997 (0.15%)	3
Bronchial obstruction ^† 1	1/997 (0.10%)	1	4/1997 (0.20%)	5
Bronchospasm ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Catarrh ^† 1	8/997 (0.80%)	12	13/1997 (0.65%)	13
Childhood asthma ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Choking ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Cough ^† 1	58/997 (5.82%)	69	115/1997 (5.76%)	145
Dysphonia ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Epistaxis ^† 1	0/997 (0.00%)	0	4/1997 (0.20%)	7
Hiccups ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Nasal congestion ^† 1	86/997 (8.63%)	113	164/1997 (8.21%)	208
Nasal obstruction ^† 1	5/997 (0.50%)	7	18/1997 (0.90%)	19
Oropharyngeal pain ^† 1	2/997 (0.20%)	2	3/1997 (0.15%)	3
Pharyngeal inflammation ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Pneumothorax ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Productive cough ^† 1	2/997 (0.20%)	2	1/1997 (0.05%)	1
Respiration abnormal ^† 1	2/997 (0.20%)	2	2/1997 (0.10%)	2
Respiratory failure ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Rhinalgia ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Rhinitis allergic ^† 1	12/997 (1.20%)	15	13/1997 (0.65%)	14
Rhinorrhoea ^† 1	65/997 (6.52%)	85	152/1997 (7.61%)	216
Sinus congestion ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Sleep apnoea syndrome ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Sneezing ^† 1	0/997 (0.00%)	0	5/1997 (0.25%)	5
Snoring ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Stridor ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Tachypnoea ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Throat irritation ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Tracheomalacia ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Upper airway obstruction ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Upper respiratory tract congestion ^† 1	3/997 (0.30%)	3	7/1997 (0.35%)	8
Upper respiratory tract inflammation ^† 1	2/997 (0.20%)	3	6/1997 (0.30%)	11
Upper respiratory tract irritation ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Vasomotor rhinitis ^† 1	5/997 (0.50%)	5	12/1997 (0.60%)	15
Wheezing ^† 1	4/997 (0.40%)	4	5/1997 (0.25%)	5
Skin and subcutaneous tissue disorders
Acne infantile ^† 1	1/997 (0.10%)	1	4/1997 (0.20%)	4
Asteatosis ^† 1	0/997 (0.00%)	0	4/1997 (0.20%)	4
Blister ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Cafe au lait spots ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Dandruff ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Dermatitis ^† 1	21/997 (2.11%)	22	44/1997 (2.20%)	44
Dermatitis allergic ^† 1	5/997 (0.50%)	5	11/1997 (0.55%)	12
Dermatitis atopic ^† 1	25/997 (2.51%)	28	56/1997 (2.80%)	59
Dermatitis contact ^† 1	16/997 (1.60%)	18	39/1997 (1.95%)	41
Dermatitis diaper ^† 1	103/997 (10.33%)	118	224/1997 (11.22%)	267
Dermatosis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Drug eruption ^† 1	3/997 (0.30%)	3	4/1997 (0.20%)	4
Dry skin ^† 1	19/997 (1.91%)	19	39/1997 (1.95%)	41
Dyshidrotic eczema ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Eczema ^† 1	52/997 (5.22%)	59	90/1997 (4.51%)	98
Eczema asteatotic ^† 1	1/997 (0.10%)	1	6/1997 (0.30%)	6
Eczema infantile ^† 1	9/997 (0.90%)	11	21/1997 (1.05%)	23
Eczema nummular ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Ephelides ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Erythema ^† 1	4/997 (0.40%)	4	3/1997 (0.15%)	3
Erythema toxicum neonatorum ^† 1	3/997 (0.30%)	3	5/1997 (0.25%)	5
Haemorrhage subcutaneous ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Hand dermatitis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Idiopathic urticaria ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Ingrowing nail ^† 1	1/997 (0.10%)	1	1/1997 (0.05%)	1
Intertrigo ^† 1	4/997 (0.40%)	4	2/1997 (0.10%)	2
Keratosis pilaris ^† 1	2/997 (0.20%)	2	5/1997 (0.25%)	5
Lichen striatus ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Macule ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Miliaria ^† 1	37/997 (3.71%)	47	60/1997 (3.00%)	71
Nail discolouration ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Neurodermatitis ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Papule ^† 1	2/997 (0.20%)	2	2/1997 (0.10%)	2
Perioral dermatitis ^† 1	2/997 (0.20%)	2	0/1997 (0.00%)	0
Petechiae ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Pityriasis alba ^† 1	4/997 (0.40%)	4	10/1997 (0.50%)	10
Pityriasis rosea ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Post inflammatory pigmentation change ^† 1	0/997 (0.00%)	0	2/1997 (0.10%)	2
Prurigo ^† 1	3/997 (0.30%)	3	6/1997 (0.30%)	6
Rash ^† 1	48/997 (4.81%)	55	93/1997 (4.66%)	108
Rash erythematous ^† 1	1/997 (0.10%)	1	3/1997 (0.15%)	3
Rash macular ^† 1	3/997 (0.30%)	3	2/1997 (0.10%)	2
Rash maculo-papular ^† 1	8/997 (0.80%)	8	17/1997 (0.85%)	17
Rash papular ^† 1	8/997 (0.80%)	8	15/1997 (0.75%)	15
Rash pruritic ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Seborrhoea ^† 1	1/997 (0.10%)	1	3/1997 (0.15%)	3
Seborrhoeic dermatitis ^† 1	17/997 (1.71%)	17	40/1997 (2.00%)	40
Skin exfoliation ^† 1	1/997 (0.10%)	1	2/1997 (0.10%)	2
Skin hypopigmentation ^† 1	2/997 (0.20%)	2	6/1997 (0.30%)	6
Skin irritation ^† 1	3/997 (0.30%)	3	15/1997 (0.75%)	18
Thermal burn ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Toxic skin eruption ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Transient neonatal pustular melanosis ^† 1	2/997 (0.20%)	2	0/1997 (0.00%)	0
Urticaria ^† 1	9/997 (0.90%)	11	21/1997 (1.05%)	25
Urticaria chronic ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Urticaria contact ^† 1	1/997 (0.10%)	2	0/1997 (0.00%)	0
Xeroderma ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Surgical and medical procedures
Circumcision ^† 1	1/997 (0.10%)	1	4/1997 (0.20%)	4
Clamping of blood vessel ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Infection prophylaxis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Oral surgery ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Scrotal operation ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
Skin lesion removal ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	2
Urethral repair ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Vascular disorders
Cyanosis ^† 1	1/997 (0.10%)	1	3/1997 (0.15%)	3
Pallor ^† 1	1/997 (0.10%)	1	0/1997 (0.00%)	0
Phlebitis ^† 1	0/997 (0.00%)	0	1/1997 (0.05%)	1
1 Term from vocabulary, MedDRA 25.1 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	Global Clinical Lead
Organization:	Astrazeneca
Phone:	+1 877-240-9479
EMail:	information.center@astrazeneca.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hammitt LL, Dagan R, Yuan Y, Baca Cots M, Bosheva M, Madhi SA, Muller WJ, Zar HJ, Brooks D, Grenham A, Wahlby Hamren U, Mankad VS, Ren P, Takas T, Abram ME, Leach A, Griffin MP, Villafana T; MELODY Study Group. Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants. N Engl J Med. 2022 Mar 3;386(9):837-846. doi: 10.1056/NEJMoa2110275.

Ginsburg AS, Srikantiah P. Respiratory syncytial virus: promising progress against a leading cause of pneumonia. Lancet Glob Health. 2021 Dec;9(12):e1644-e1645. doi: 10.1016/S2214-109X(21)00455-1. Epub 2021 Nov 11. No abstract available.

Layout table for additonal information

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT03979313
Obsolete Identifiers:	NCT05238974
Other Study ID Numbers:	D5290C00004 2019-000114-11 ( EudraCT Number )
First Submitted:	May 30, 2019
First Posted:	June 7, 2019
Results First Submitted:	August 21, 2023
Results First Posted:	February 28, 2024
Last Update Posted:	February 28, 2024

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