Trial Outcomes & Findings for Synagis® Liquid 50mg, 100mg for Intramuscular Injection Special Investigation in Immunocompromised Children With Synagis® (NCT NCT02016690)
NCT ID: NCT02016690
Last Updated: 2017-03-20
Results Overview
An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. Adverse events were documented on the case report form (CRF).
Recruitment status
COMPLETED
Target enrollment
312 participants
Primary outcome timeframe
From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Results posted on
2017-03-20
Participant Flow
Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period.
Participant milestones
| Measure |
Immunocompromised Children
Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
|
|---|---|
|
Overall Study
STARTED
|
312
|
|
Overall Study
Treated
|
312
|
|
Overall Study
Safety Analysis Set (SAS)
|
304
|
|
Overall Study
COMPLETED
|
288
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
Immunocompromised Children
Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
|
|---|---|
|
Overall Study
Excluded from SAS: Enrollment violation
|
2
|
|
Overall Study
Excluded from SAS: Duplication
|
2
|
|
Overall Study
Excluded from SAS: Early treatment
|
2
|
|
Overall Study
Excluded from SAS: Ineligible for study
|
2
|
|
Overall Study
Did not meet inclusion criteria
|
13
|
|
Overall Study
Hospitalized for RSV at study start
|
3
|
Baseline Characteristics
Synagis® Liquid 50mg, 100mg for Intramuscular Injection Special Investigation in Immunocompromised Children With Synagis®
Baseline characteristics by cohort
| Measure |
Immunocompromised Children
n=304 Participants
Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
|
|---|---|
|
Age, Continuous
|
11.9 months
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
187 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
297 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Others
|
4 Participants
n=5 Participants
|
|
Age at the start of treatment
≤ 1 month
|
31 Participants
n=5 Participants
|
|
Age at the start of treatment
> 1 and ≤ 3 months
|
24 Participants
n=5 Participants
|
|
Age at the start of treatment
> 3 and ≤ 6 months
|
31 Participants
n=5 Participants
|
|
Age at the start of treatment
> 6 and ≤ 12 months
|
81 Participants
n=5 Participants
|
|
Age at the start of treatment
> 12 and ≤ 24 months
|
137 Participants
n=5 Participants
|
|
Age at the start of treatment
> 24 months
|
0 Participants
n=5 Participants
|
|
Body weight at the start of treatment
< 1000 grams
|
0 Participants
n=5 Participants
|
|
Body weight at the start of treatment
≥ 1000 and < 1500 grams
|
0 Participants
n=5 Participants
|
|
Body weight at the start of treatment
≥ 1500 and < 2500 grams
|
1 Participants
n=5 Participants
|
|
Body weight at the start of treatment
≥ 2500 and < 5000 grams
|
52 Participants
n=5 Participants
|
|
Body weight at the start of treatment
≥ 5000 and < 10000 grams
|
202 Participants
n=5 Participants
|
|
Body weight at the start of treatment
≥ 10000 and < 15000 grams
|
45 Participants
n=5 Participants
|
|
Body weight at the start of treatment
≥ 15000 grams
|
1 Participants
n=5 Participants
|
|
Body weight at the start of treatment
Not specified
|
3 Participants
n=5 Participants
|
|
Gestational age
< 22 weeks
|
0 Participants
n=5 Participants
|
|
Gestational age
≥ 22 and < 37 weeks
|
56 Participants
n=5 Participants
|
|
Gestational age
≥ 37 and < 42 weeks
|
237 Participants
n=5 Participants
|
|
Gestational age
≥ 42 weeks
|
1 Participants
n=5 Participants
|
|
Gestational age
Not specified
|
10 Participants
n=5 Participants
|
|
Body weight at birth
< 1000 grams
|
0 Participants
n=5 Participants
|
|
Body weight at birth
≥ 1000 and ≤ 1500 grams
|
4 Participants
n=5 Participants
|
|
Body weight at birth
≥ 1500 and ≤ 2500 grams
|
80 Participants
n=5 Participants
|
|
Body weight at birth
≥ 2500 and ≤ 4000 grams
|
207 Participants
n=5 Participants
|
|
Body weight at birth
≥ 4000 grams
|
2 Participants
n=5 Participants
|
|
Body weight at birth
Not specified
|
11 Participants
n=5 Participants
|
|
Number of smokers in the household
0 smokers
|
184 Participants
n=5 Participants
|
|
Number of smokers in the household
≥ 1 smokers
|
40 Participants
n=5 Participants
|
|
Number of smokers in the household
Not specified
|
80 Participants
n=5 Participants
|
|
Familial predisposition to hypersensitivity
No
|
180 Participants
n=5 Participants
|
|
Familial predisposition to hypersensitivity
Yes
|
34 Participants
n=5 Participants
|
|
Familial predisposition to hypersensitivity
Unknown
|
84 Participants
n=5 Participants
|
|
Familial predisposition to hypersensitivity
Not specified
|
6 Participants
n=5 Participants
|
|
Participant's predisposition to hypersensitivity
No
|
245 Participants
n=5 Participants
|
|
Participant's predisposition to hypersensitivity
Yes- asthma
|
11 Participants
n=5 Participants
|
|
Participant's predisposition to hypersensitivity
Yes- allergic bronchitis
|
1 Participants
n=5 Participants
|
|
Participant's predisposition to hypersensitivity
Yes- allergic rhinitis
|
4 Participants
n=5 Participants
|
|
Participant's predisposition to hypersensitivity
Yes- allergic dermatitis
|
4 Participants
n=5 Participants
|
|
Participant's predisposition to hypersensitivity
Yes- food allergy
|
11 Participants
n=5 Participants
|
|
Participant's predisposition to hypersensitivity
Yes- drug allergy
|
3 Participants
n=5 Participants
|
|
Participant's predisposition to hypersensitivity
Yes- others
|
1 Participants
n=5 Participants
|
|
Participant's predisposition to hypersensitivity
Unknown
|
28 Participants
n=5 Participants
|
|
Comorbidity
No
|
120 Participants
n=5 Participants
|
|
Comorbidity
Yes- renal disease
|
18 Participants
n=5 Participants
|
|
Comorbidity
Yes- hepatic disease
|
21 Participants
n=5 Participants
|
|
Comorbidity
Yes- respiratory disease
|
50 Participants
n=5 Participants
|
|
Comorbidity
Yes- cardiovascular disease
|
45 Participants
n=5 Participants
|
|
Comorbidity
Yes- others
|
142 Participants
n=5 Participants
|
|
Comorbidity
Unknown
|
1 Participants
n=5 Participants
|
|
Lower Respiratory Tract Infection score at the start of treatment
0
|
289 Participants
n=5 Participants
|
|
Lower Respiratory Tract Infection score at the start of treatment
1
|
5 Participants
n=5 Participants
|
|
Lower Respiratory Tract Infection score at the start of treatment
2
|
4 Participants
n=5 Participants
|
|
Lower Respiratory Tract Infection score at the start of treatment
3
|
4 Participants
n=5 Participants
|
|
Lower Respiratory Tract Infection score at the start of treatment
4
|
1 Participants
n=5 Participants
|
|
Lower Respiratory Tract Infection score at the start of treatment
5
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeksPopulation: Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period.
An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. Adverse events were documented on the case report form (CRF).
Outcome measures
| Measure |
Immunocompromised Children
n=304 Participants
Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
|
|---|---|
|
Number of Participants With Adverse Events
|
99 Participants
|
PRIMARY outcome
Timeframe: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeksPopulation: Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period.
A serious adverse event was defined as any untoward medical occurrence in a participant that the investigator believed to be causally related to the study treatment and met at least one of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or important medical event requiring medical or surgical intervention to prevent serious outcome. Serious adverse events were documented on the case report form (CRF).
Outcome measures
| Measure |
Immunocompromised Children
n=304 Participants
Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
|
|---|---|
|
Number of Participants With Serious Adverse Events
|
53 Participants
|
PRIMARY outcome
Timeframe: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeksPopulation: Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period.
An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. If a causal relationship with palivizumab was: "Related", "Causality cannot be ruled out", or "Not assessable" as determined by the investigator, it was classified as an adverse drug reaction (ADR). An AE was considered a serious adverse event (SAE) and a serious adverse drug reaction (SADR) if the severity of the AE or ADR was any one of the following, as determined by the investigator: "Death", "Life-threatening condition", "Hospitalization or prolonged hospitalization", "Persistent or significant disability", or "Other medically important condition". Information about AEs and ADRs was documented on the case report form (CRF).
Outcome measures
| Measure |
Immunocompromised Children
n=304 Participants
Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
|
|---|---|
|
Number of Participants With Adverse Drug Reactions
|
25 Participants
|
SECONDARY outcome
Timeframe: From the first administration of palivizumab up to the last administration of palivizumab, up to 36 weeksPopulation: Participants with available data
The Lower Respiratory Tract Infection (LRI) Score ranged from 0 (well or baseline); 1 (Upper Respiratory tract Infection \[URI\]), mild); 2 (LRI); 3 (LRI, moderate); 4 (LRI, severe) to 5 (Respiratory Failure). Components of the score included respiratory rate per minute, oxygen saturation, and physical findings of LRI. LRI scores were documented on the case report form (CRF).
Outcome measures
| Measure |
Immunocompromised Children
n=288 Participants
Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
|
|---|---|
|
Change in Lower Respiratory Tract Infection (LRI) Score During the Study
5 doses
|
0.1 units on a scale
Standard Deviation 0.4
|
|
Change in Lower Respiratory Tract Infection (LRI) Score During the Study
1 dose
|
0.1 units on a scale
Standard Deviation 0.6
|
|
Change in Lower Respiratory Tract Infection (LRI) Score During the Study
2 doses
|
0.1 units on a scale
Standard Deviation 0.6
|
|
Change in Lower Respiratory Tract Infection (LRI) Score During the Study
3 doses
|
0.1 units on a scale
Standard Deviation 0.6
|
|
Change in Lower Respiratory Tract Infection (LRI) Score During the Study
4 doses
|
0.1 units on a scale
Standard Deviation 0.6
|
|
Change in Lower Respiratory Tract Infection (LRI) Score During the Study
6 doses
|
0.1 units on a scale
Standard Deviation 0.3
|
|
Change in Lower Respiratory Tract Infection (LRI) Score During the Study
7 doses
|
0.0 units on a scale
Standard Deviation 0.2
|
|
Change in Lower Respiratory Tract Infection (LRI) Score During the Study
8 doses
|
0.1 units on a scale
Standard Deviation 0.3
|
|
Change in Lower Respiratory Tract Infection (LRI) Score During the Study
9 doses
|
0.0 units on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeksPopulation: Participants with available data
Hospitalization due to RSV infection or the presence/absence of positive RSV antigen test results during hospitalization was documented on the case report form (CRF).
Outcome measures
| Measure |
Immunocompromised Children
n=5 Participants
Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
|
|---|---|
|
Number of Participants Hospitalized Due to Respiratory Syncytial Virus (RSV) Infection
|
2 Participants
|
SECONDARY outcome
Timeframe: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeksPopulation: Participants with available data
The date of hospitalization due to RSV infection and the date of hospital discharge were documented on the case report form (CRF).
Outcome measures
| Measure |
Immunocompromised Children
n=2 Participants
Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
|
|---|---|
|
Mean Hospitalization Length Due to Respiratory Syncytial Virus (RSV) Infection
|
9.5 days
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeksPopulation: Participants with available data
The presence/absence of respiratory support, (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) the start and end dates of respiratory support, and the dates of hospitalization and discharge were documented on the case report form (CRF).
Outcome measures
| Measure |
Immunocompromised Children
n=2 Participants
Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
|
|---|---|
|
Number of Hospitalized Participants Requiring Respiratory Support
|
1 Participants
|
SECONDARY outcome
Timeframe: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeksPopulation: Participants with available data
The presence/absence of respiratory support (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) and the start and end dates of respiratory support were documented on the case report form (CRF).
Outcome measures
| Measure |
Immunocompromised Children
n=3 Participants
Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
|
|---|---|
|
Mean Duration of Respiratory Support
|
40.0 days
Standard Deviation 62.4
|
Adverse Events
Immunocompromised Children
Serious events: 53 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Immunocompromised Children
n=304 participants at risk
Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
|
|---|---|
|
Infections and infestations
Bacteraemia
|
0.99%
3/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Bronchitis
|
0.99%
3/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Gastroenteritis
|
0.99%
3/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Gastroenteritis viral
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Infection
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Influenza
|
0.66%
2/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.66%
2/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Peritonitis
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Pneumonia
|
2.0%
6/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Sepsis
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Septic shock
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Tonsillitis
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Bronchitis viral
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Pneumonia bacterial
|
0.66%
2/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.66%
2/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Device related infection
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nephroblastoma
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.66%
2/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Blood and lymphatic system disorders
Histiocytosis haematophagic
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.99%
3/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Immune system disorders
Chronic graft versus host disease
|
0.66%
2/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Endocrine disorders
Adrenal disorder
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Nervous system disorders
Febrile convulsion
|
0.66%
2/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Nervous system disorders
Neurological symptom
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Eye disorders
Eyelid oedema
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Cardiac disorders
Bradycardia
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Cardiac disorders
Cardiac failure
|
0.66%
2/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Vascular disorders
Hypertension
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.3%
4/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Hepatobiliary disorders
Cholangitis
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Hepatobiliary disorders
Liver disorder
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Renal and urinary disorders
Renal impairment
|
0.66%
2/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Congenital, familial and genetic disorders
Anal atresia
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Congenital, familial and genetic disorders
X-linked lymphoproliferative syndrome
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Congenital, familial and genetic disorders
Omenn syndrome
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
General disorders
Condition aggravated
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
General disorders
Pyrexia
|
0.66%
2/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Investigations
Neutrophil count decreased
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Investigations
Norovirus test positive
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
Other adverse events
| Measure |
Immunocompromised Children
n=304 participants at risk
Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
|
|---|---|
|
Infections and infestations
Acute sinusitis
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Bronchitis
|
0.99%
3/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Cellulitis
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Conjunctivitis
|
0.99%
3/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Croup infectious
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Exanthema subitum
|
0.99%
3/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Gastroenteritis
|
0.99%
3/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Gastroenteritis viral
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Influenza
|
0.99%
3/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
0.66%
2/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Pneumonia
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Sinusitis
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Viral pharyngitis
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Viral rash
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Catheter site infection
|
0.99%
3/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Enteritis infectious
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Clostridial infection
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.66%
2/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Enterocolitis viral
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Device related infection
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Viral rhinitis
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Enterocolitis bacterial
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Metapneumovirus infection
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Tinea manuum
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.0%
9/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Blood and lymphatic system disorders
Histiocytosis haematophagic
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Immune system disorders
Graft versus host disease
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Immune system disorders
Hypersensitivity
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.66%
2/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Immune system disorders
Engraftment syndrome
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Nervous system disorders
Epilepsy
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Eye disorders
Uveitis
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Vascular disorders
Hypertension
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.66%
2/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
7.2%
22/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Fibrinous bronchitis
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Gastrointestinal disorders
Ascites
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Gastrointestinal disorders
Constipation
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
6/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Gastrointestinal disorders
Stomatitis
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.66%
2/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Hepatobiliary disorders
Liver disorder
|
0.66%
2/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Skin and subcutaneous tissue disorders
Penile ulceration
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
General disorders
Pain
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
General disorders
Pyrexia
|
1.3%
4/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Investigations
Blood culture positive
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Investigations
Neutrophil count decreased
|
0.66%
2/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Investigations
White blood cell count decreased
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Investigations
Antithrombin III decreased
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Investigations
Aspergillus test positive
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Injury, poisoning and procedural complications
Frostbite
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.33%
1/304 • All adverse events were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 44 weeks.
|
Additional Information
Global Medical Services
AbbVie
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER