Synagis® Liquid 50mg, 100mg for Intramuscular Injection Special Investigation in Immunocompromised Children With Synagis®

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02016690
• Collaborator: (none)
• Enrollment: 312
• Duration (Months): 24

Study Details

Study Description

Brief Summary

This post marketing observational study (PMOS) was conducted in Japan during the 2013-2014 and 2014-2015 Respiratory Syncytial Virus (RSV) seasons to assess the safety and effectiveness of palivizumab for the prevention of serious lower respiratory tract infection caused by RSV in participants 24 months of age and under, who have an immunocompromised medical condition (e.g., combined immunodeficiency disease, antibody deficiency, or other types of immunodeficiency; HIV infection; recovering from organ or bone marrow transplantation; on chemotherapy; on high-dose corticosteroid therapy; on immunosuppressants) or who have Down syndrome.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus Infection

Detailed Description

Palivizumab was prescribed according to the local label and independently of the decision to enroll participants in the study. Palivizumab was administered monthly throughout the Respiratory Syncytial Virus (RSV) infection seasons via intramuscular injection at a dose of 15 mg/kg of body weight. Survey forms were collected after the observation period. The number of adverse events and the frequency of hospitalizations due to RSV infections in surveyed participants were assessed to evaluate the safety and effectiveness of palivizumab.

Study Design

• Study Type: Observational
• Actual Enrollment: 312 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Synagis® Liquid 50mg, 100mg for Intramuscular Injection Special Investigation in Immunocompromised Children With Synagis®
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Immunocompromised children Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events [From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks]

   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).

2. Number of Participants With Serious Adverse Events [From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks]

   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).

3. Number of Participants With Adverse Drug Reactions [From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks]

   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).

Secondary Outcome Measures

1. Change in Lower Respiratory Tract Infection (LRI) Score During the Study [From the first administration of palivizumab up to the last administration of palivizumab, up to 36 weeks]

   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).

2. Number of Participants Hospitalized Due to Respiratory Syncytial Virus (RSV) Infection [From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks]

   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).

3. Mean Hospitalization Length Due to Respiratory Syncytial Virus (RSV) Infection [From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks]

   The date of hospitalization due to RSV infection and the date of hospital discharge were documented on the case report form (CRF).

4. Number of Hospitalized Participants Requiring Respiratory Support [From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks]

   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).

5. Mean Duration of Respiratory Support [From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 24 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Availability of a parent or legal guardian who was capable and willing to give written informed consent for his/her newborn, infant or young child to participate in the study

2. Participants receiving palivizumab for prevention of serious lower respiratory tract disease caused by RSV infection

3. Newborns, infants, or young children 24 months of age and under who have an immunocompromised medical condition:

• combined immunodeficiency, (severe combined immunodeficiency, X-linked hyper-immunoglobulin M (IgM) syndrome, etc.), antibody deficiency (X-linked agammaglobulinemia,common variable immunodeficiency, non-X-linked hyper-IgM syndrome,etc.) or other immunodeficiency (Wiskott-Aldrich syndrome, etc.)

• acquired T cell dysfunction ( such as human immunodeficiency virus (HIV) infection etc.)

• history of past organ transplantation

• history of past bone marrow transplantation

• receiving immunosuppressive chemotherapy

• receiving systemic high-dose corticosteroid therapy (prednisone equivalents ≥ 0.5 mg/kg/every other day, other than inhaler or topical use), or

• receiving other immunosuppressive therapy (azathioprine, methotrexate, mizoribine, mycophenolate mofetil, cyclophosphamide, cyclosporine, tacrolimus, cytokine inhibitors, etc.)

• receiving biologics (including cytokine inhibitors)

• Others (nephrotic syndrome, chronic peritoneal dialysis, hemodialysis)

1. Newborns, infants, or young children age of 24 months and under who have Down syndrome without a current hemodynamically significant Congenital Heart Disease. The participant must have had an experience with persistent respiratory symptoms or regular outpatient treatment due to respiratory tract infection prior to current RSV season.

Exclusion criteria:

1. Participants included in the Contraindications section of the package insert

2. Participants with known hypersensitivity to the ingredients of palivizumab

3. Participants with a known positive RSV infection before hospitalization

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: Osamu Mikami, MD, PhD, AbbVie GK.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02016690
• Other Study ID Numbers: P14-296
• First Posted: Dec 20, 2013
• Last Update Posted: Mar 20, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by AbbVie: Prevention of severe RSV infection; Respiratory syncytial virus (RSV) infection; Down Syndrome; Immunocompromised; Effectiveness of palivizumab
• Additional relevant MeSH terms: Infections; Respiratory Syncytial Virus Infections

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Immunocompromised Children
Arm/Group Description	Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
Period Title: Overall Study
STARTED	312
Treated	312
Safety Analysis Set (SAS)	304
COMPLETED	288
NOT COMPLETED	24

Baseline Characteristics

Arm/Group Title	Immunocompromised Children
Arm/Group Description	Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
Overall Participants	304
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	11.9 (7.5)
Sex: Female, Male (Count of Participants)
Female	117 38.5%
Male	187 61.5%
Race/Ethnicity, Customized (Count of Participants)
Japanese	297 97.7%
Black	0 0%
White	0 0%
Asian	3 1%
Others	4 1.3%
Age at the start of treatment (Count of Participants)
≤ 1 month	31 10.2%
> 1 and ≤ 3 months	24 7.9%
> 3 and ≤ 6 months	31 10.2%
> 6 and ≤ 12 months	81 26.6%
> 12 and ≤ 24 months	137 45.1%
> 24 months	0 0%
Body weight at the start of treatment (Count of Participants)
< 1000 grams	0 0%
≥ 1000 and < 1500 grams	0 0%
≥ 1500 and < 2500 grams	1 0.3%
≥ 2500 and < 5000 grams	52 17.1%
≥ 5000 and < 10000 grams	202 66.4%
≥ 10000 and < 15000 grams	45 14.8%
≥ 15000 grams	1 0.3%
Not specified	3 1%
Gestational age (Count of Participants)
< 22 weeks	0 0%
≥ 22 and < 37 weeks	56 18.4%
≥ 37 and < 42 weeks	237 78%
≥ 42 weeks	1 0.3%
Not specified	10 3.3%
Body weight at birth (Count of Participants)
< 1000 grams	0 0%
≥ 1000 and ≤ 1500 grams	4 1.3%
≥ 1500 and ≤ 2500 grams	80 26.3%
≥ 2500 and ≤ 4000 grams	207 68.1%
≥ 4000 grams	2 0.7%
Not specified	11 3.6%
Number of smokers in the household (Count of Participants)
0 smokers	184 60.5%
≥ 1 smokers	40 13.2%
Not specified	80 26.3%
Familial predisposition to hypersensitivity (Count of Participants)
No	180 59.2%
Yes	34 11.2%
Unknown	84 27.6%
Not specified	6 2%
Participant's predisposition to hypersensitivity (Count of Participants)
No	245 80.6%
Yes- asthma	11 3.6%
Yes- allergic bronchitis	1 0.3%
Yes- allergic rhinitis	4 1.3%
Yes- allergic dermatitis	4 1.3%
Yes- food allergy	11 3.6%
Yes- drug allergy	3 1%
Yes- others	1 0.3%
Unknown	28 9.2%
Comorbidity (Count of Participants)
No	120 39.5%
Yes- renal disease	18 5.9%
Yes- hepatic disease	21 6.9%
Yes- respiratory disease	50 16.4%
Yes- cardiovascular disease	45 14.8%
Yes- others	142 46.7%
Unknown	1 0.3%
Lower Respiratory Tract Infection score at the start of treatment (Count of Participants)
0	289 95.1%
1	5 1.6%
2	4 1.3%
3	4 1.3%
4	1 0.3%
5	1 0.3%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events
Description	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).
Time Frame	From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Immunocompromised Children
Arm/Group Description	Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
Measure Participants	304
Count of Participants [Participants]	99 32.6%

2. Primary Outcome

Title	Number of Participants With Serious Adverse Events
Description	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).
Time Frame	From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Immunocompromised Children
Arm/Group Description	Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
Measure Participants	304
Count of Participants [Participants]	53 17.4%

3. Primary Outcome

Title	Number of Participants With Adverse Drug Reactions
Description	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).
Time Frame	From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Immunocompromised Children
Arm/Group Description	Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
Measure Participants	304
Count of Participants [Participants]	25 8.2%

4. Secondary Outcome

Title	Change in Lower Respiratory Tract Infection (LRI) Score During the Study
Description	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).
Time Frame	From the first administration of palivizumab up to the last administration of palivizumab, up to 36 weeks

Outcome Measure Data

Analysis Population Description

Participants with available data

Arm/Group Title	Immunocompromised Children
Arm/Group Description	Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
Measure Participants	288
1 dose	0.1 (0.6)
2 doses	0.1 (0.6)
3 doses	0.1 (0.6)
4 doses	0.1 (0.6)
5 doses	0.1 (0.4)
6 doses	0.1 (0.3)
7 doses	0.0 (0.2)
8 doses	0.1 (0.3)
9 doses	0.0 (0.0)

5. Secondary Outcome

Title	Number of Participants Hospitalized Due to Respiratory Syncytial Virus (RSV) Infection
Description	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).
Time Frame	From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks

Outcome Measure Data

Analysis Population Description

Participants with available data

Arm/Group Title	Immunocompromised Children
Arm/Group Description	Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
Measure Participants	5
Count of Participants [Participants]	2 0.7%

6. Secondary Outcome

Title	Mean Hospitalization Length Due to Respiratory Syncytial Virus (RSV) Infection
Description	The date of hospitalization due to RSV infection and the date of hospital discharge were documented on the case report form (CRF).
Time Frame	From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks

Outcome Measure Data

Analysis Population Description

Participants with available data

Arm/Group Title	Immunocompromised Children
Arm/Group Description	Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
Measure Participants	2
Mean (Standard Deviation) [days]	9.5 (2.1)

7. Secondary Outcome

Title	Number of Hospitalized Participants Requiring Respiratory Support
Description	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).
Time Frame	From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks

Outcome Measure Data

Analysis Population Description

Participants with available data

Arm/Group Title	Immunocompromised Children
Arm/Group Description	Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
Measure Participants	2
Count of Participants [Participants]	1 0.3%

8. Secondary Outcome

Title	Mean Duration of Respiratory Support
Description	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).
Time Frame	From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks

Outcome Measure Data

Analysis Population Description

Participants with available data

Arm/Group Title	Immunocompromised Children
Arm/Group Description	Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
Measure Participants	3
Mean (Standard Deviation) [days]	40.0 (62.4)

Adverse Events

Time Frame	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.
Arm/Group Title	Immunocompromised Children
Arm/Group Description	Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
All Cause Mortality
	Immunocompromised Children
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Immunocompromised Children
	Affected / at Risk (%)	# Events
Total	53/304 (17.4%)
Blood and lymphatic system disorders
Anaemia	1/304 (0.3%)
Coagulopathy	1/304 (0.3%)
Disseminated intravascular coagulation	1/304 (0.3%)
Febrile neutropenia	2/304 (0.7%)
Haemolysis	1/304 (0.3%)
Pancytopenia	1/304 (0.3%)
Histiocytosis haematophagic	1/304 (0.3%)
Bone marrow failure	3/304 (1%)
Cardiac disorders
Bradycardia	1/304 (0.3%)
Cardiac failure	2/304 (0.7%)
Congenital, familial and genetic disorders
Anal atresia	1/304 (0.3%)
X-linked lymphoproliferative syndrome	1/304 (0.3%)
Omenn syndrome	1/304 (0.3%)
Endocrine disorders
Adrenal disorder	1/304 (0.3%)
Eye disorders
Eyelid oedema	1/304 (0.3%)
Gastrointestinal disorders
Vomiting	1/304 (0.3%)
General disorders
Condition aggravated	1/304 (0.3%)
Pyrexia	2/304 (0.7%)
Hepatobiliary disorders
Cholangitis	1/304 (0.3%)
Hepatic failure	1/304 (0.3%)
Hepatic function abnormal	1/304 (0.3%)
Liver disorder	1/304 (0.3%)
Drug-induced liver injury	1/304 (0.3%)
Immune system disorders
Chronic graft versus host disease	2/304 (0.7%)
Infections and infestations
Bacteraemia	3/304 (1%)
Bronchitis	3/304 (1%)
Cytomegalovirus infection	1/304 (0.3%)
Epstein-Barr virus infection	1/304 (0.3%)
Gastroenteritis	3/304 (1%)
Gastroenteritis viral	1/304 (0.3%)
Infection	1/304 (0.3%)
Influenza	2/304 (0.7%)
Lower respiratory tract infection	2/304 (0.7%)
Peritonitis	1/304 (0.3%)
Pneumonia	6/304 (2%)
Sepsis	1/304 (0.3%)
Septic shock	1/304 (0.3%)
Tonsillitis	1/304 (0.3%)
Bronchitis viral	1/304 (0.3%)
Pneumonia bacterial	2/304 (0.7%)
Respiratory syncytial virus infection	2/304 (0.7%)
Device related infection	1/304 (0.3%)
Investigations
Neutrophil count decreased	1/304 (0.3%)
Norovirus test positive	1/304 (0.3%)
Metabolism and nutrition disorders
Hypoalbuminaemia	1/304 (0.3%)
Hypophagia	1/304 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant	1/304 (0.3%)
Nephroblastoma	1/304 (0.3%)
Malignant neoplasm progression	1/304 (0.3%)
Nervous system disorders
Febrile convulsion	2/304 (0.7%)
Neurological symptom	1/304 (0.3%)
Renal and urinary disorders
Renal impairment	2/304 (0.7%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema	1/304 (0.3%)
Asthma	4/304 (1.3%)
Hypoxia	1/304 (0.3%)
Pulmonary hypertension	1/304 (0.3%)
Respiratory arrest	1/304 (0.3%)
Respiratory disorder	1/304 (0.3%)
Respiratory failure	1/304 (0.3%)
Upper respiratory tract inflammation	1/304 (0.3%)
Skin and subcutaneous tissue disorders
Rash	1/304 (0.3%)
Vascular disorders
Hypertension	1/304 (0.3%)
Other (Not Including Serious) Adverse Events
	Immunocompromised Children
	Affected / at Risk (%)	# Events
Total	67/304 (22%)
Blood and lymphatic system disorders
Anaemia	1/304 (0.3%)
Febrile neutropenia	9/304 (3%)
Histiocytosis haematophagic	1/304 (0.3%)
Endocrine disorders
Adrenal insufficiency	1/304 (0.3%)
Eye disorders
Uveitis	1/304 (0.3%)
Gastrointestinal disorders
Abdominal pain	1/304 (0.3%)
Ascites	1/304 (0.3%)
Constipation	1/304 (0.3%)
Diarrhoea	6/304 (2%)
Enterocolitis	1/304 (0.3%)
Nausea	1/304 (0.3%)
Stomatitis	1/304 (0.3%)
General disorders
Pain	1/304 (0.3%)
Pyrexia	4/304 (1.3%)
Hepatobiliary disorders
Hepatic function abnormal	2/304 (0.7%)
Liver disorder	2/304 (0.7%)
Immune system disorders
Graft versus host disease	1/304 (0.3%)
Hypersensitivity	1/304 (0.3%)
Hypogammaglobulinaemia	2/304 (0.7%)
Engraftment syndrome	1/304 (0.3%)
Infections and infestations
Acute sinusitis	1/304 (0.3%)
Bronchitis	3/304 (1%)
Cellulitis	1/304 (0.3%)
Conjunctivitis	3/304 (1%)
Croup infectious	1/304 (0.3%)
Cytomegalovirus infection	1/304 (0.3%)
Exanthema subitum	3/304 (1%)
Gastroenteritis	3/304 (1%)
Gastroenteritis viral	1/304 (0.3%)
Influenza	3/304 (1%)
Nasopharyngitis	2/304 (0.7%)
Pneumonia	1/304 (0.3%)
Pseudomembranous colitis	1/304 (0.3%)
Sinusitis	1/304 (0.3%)
Upper respiratory tract infection	1/304 (0.3%)
Viral pharyngitis	1/304 (0.3%)
Viral rash	1/304 (0.3%)
Catheter site infection	3/304 (1%)
Enteritis infectious	1/304 (0.3%)
Clostridial infection	1/304 (0.3%)
Respiratory syncytial virus infection	2/304 (0.7%)
Enterocolitis viral	1/304 (0.3%)
Device related infection	1/304 (0.3%)
Viral rhinitis	1/304 (0.3%)
Enterocolitis bacterial	1/304 (0.3%)
Metapneumovirus infection	1/304 (0.3%)
Tinea manuum	1/304 (0.3%)
Gastroenteritis norovirus	1/304 (0.3%)
Injury, poisoning and procedural complications
Femur fracture	1/304 (0.3%)
Frostbite	1/304 (0.3%)
Vaccination complication	1/304 (0.3%)
Postoperative ileus	1/304 (0.3%)
Investigations
Alanine aminotransferase increased	1/304 (0.3%)
Blood culture positive	1/304 (0.3%)
Neutrophil count decreased	2/304 (0.7%)
White blood cell count decreased	1/304 (0.3%)
Antithrombin III decreased	1/304 (0.3%)
Aspergillus test positive	1/304 (0.3%)
Metabolism and nutrition disorders
Hypokalaemia	1/304 (0.3%)
Hyponatraemia	1/304 (0.3%)
Lactose intolerance	1/304 (0.3%)
Nervous system disorders
Epilepsy	1/304 (0.3%)
Renal and urinary disorders
Nephrotic syndrome	1/304 (0.3%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/304 (0.3%)
Cough	1/304 (0.3%)
Interstitial lung disease	1/304 (0.3%)
Allergic rhinitis	1/304 (0.3%)
Rhinorrhoea	2/304 (0.7%)
Upper respiratory tract inflammation	22/304 (7.2%)
Fibrinous bronchitis	1/304 (0.3%)
Skin and subcutaneous tissue disorders
Dermatitis	1/304 (0.3%)
Penile ulceration	1/304 (0.3%)
Rash	1/304 (0.3%)
Skin ulcer	1/304 (0.3%)
Vascular disorders
Hypertension	1/304 (0.3%)

Limitations/Caveats

The study population was a very specific, defined group, observed in the context of daily practice.The results of this study of the safety and effectiveness of palivizumab may not be applicable to the general population of healthy infants in Japan.

More Information

Certain Agreements

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

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.