Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany

• Sponsor: AbbVie (prior sponsor, Abbott) (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01155193
• Collaborator: (none)
• Enrollment: 30,804
• Actual Duration (Months): 167

Study Details

Study Description

Brief Summary

The SYNAGIS Registry was carried out in order to gather comprehensive real-world data on the use of palivizumab in children at high risk for serious respiratory syncytial virus (RSV) disease. This registry was designed as a post-marketing observational study, and conducted with the aim of collecting data on palivizumab administration, the risk factors for complicated RSV disease, frequency of hospitalizations, and drug adherence.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus Infections

Detailed Description

Each participant included in this study was observed during his/her palivizumab prophylaxis during the prevailing RSV season. According to the requirements for non-interventional or observational studies, no diagnostic or monitoring procedures were applied to the participants included in the study other than those which would ordinarily be applied in the course of the individual therapeutic strategy. Only data which were part of routine medical care were collected.

Data collection was conducted initially in season 2002/2003 using paper-based case report forms (CRFs); beginning in season 2008/2009 a protected internet-based data entry platform was used. Both the paper-based CRFs and the electronic system were subject to changes during the whole time of the registry.

Data collection for registry seasons 2002/2003 - 2006/2007 was conducted by use of paper-based CRFs and hospitalization forms. Corresponding results were published in 2011 and are hence depicted together and reported here as a separate reporting group.

Registry seasons 2007/2008 and 2008/2009 were considered transitional years in the process of switching the type of data collection to an electronic CRF (eCRF) system. Although data collection of registry 2007/2008 was still paper-based, it was not included in the original publication and hence, results are reported separately. In season 2008/2009 the mode of data collection was switched from paper-based CRFs to an eCRF system, however, several physicians still used the paper-based CRFs for documentation. In order to use all documentations and lose as few data as possible, results for 2008/2009 are based on a combination of paper-based CRF and eCRF data. Hence, it was decided to keep the results for 08/09 separate from the depiction of the homogenous, eCRF-based results of the following seasons.

Data collection for registry 09/10 - 15/16 was implemented by an eCRF system. Corresponding results are therefore depicted together in one reporting group.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 30804 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective, Non-interventional Observation Study for the Use of Palivizumab in High-risk Children in Germany- SYNAGIS
• Actual Study Start Date: Sep 1, 2002
• Actual Primary Completion Date: Jul 31, 2016
• Actual Study Completion Date: Jul 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Palivizumab Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With RSV-associated Hospitalization [During RSV season (September to June) from 2002 to 2016]

Secondary Outcome Measures

1. Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08 [During RSV season (September to June) from 2002 to 2008]

   Hospitalization due to RSV was documented on a separate hospitalization form. The data below represent the number of hospitalizations documented on forms; some participants may have had more than one hospitalization. Multiple entries for discharge diagnosis were possible.

2. Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16 [During RSV season (September to June) from 2008 to 2016]

   In the season 2008/09, the eCRF system for data collection was introduced. Hospitalization due to RSV infection was documented on a separate hospitalization form in the electronic case report form (eCRF). Physicians were asked to specify a primary diagnosis at hospital discharge.

3. Presence of Complications During Hospitalization [During RSV season (September to June) from 2002 to 2016]

4. Parental Cooperation in Registries 02/03 - 06/07 and 07/08 [During RSV season (September to June) from 2002 to 2008]

   Cooperation of parents with the prophylaxis regimen was categorized as very good, good, moderate, bad or very bad.

5. Parental Cooperation for Registry 08/09 and 09/10 - 15/16 [During RSV season (September to June) from 2008 to 2016]

   Cooperation of parents with the prophylaxis regimen was evaluated per injection in registry 08/09 and 09/10 - 15/16. The categories for cooperation ratings were changed to good, satisfying, or bad: Good: all palivizumab doses could be administered as planned; Satisfying: a single palivizumab dose was missed by the parents; Bad: more than one palivizumab doses was missed by the parents.

6. Mean Number of Palivizumab Injections [During RSV season (September to June) from 2002 to 2016]

   The mean number of palivizumab injections per participant, per season.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the Respiratory syncytial virus season

• Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months.

• Children less than 2 years of age and with hemodynamically significant congenital heart disease.

Exclusion Criteria:

• Children with known hypersensitivity to palivizumab or any component of the formulation, or other humanized monoclonal antibodies

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie (prior sponsor, Abbott)

Investigators

• Study Director: Sandra Bloch, MD, AbbVie Deutschland GmbH & Co. KG, Medical Department

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: AbbVie (prior sponsor, Abbott)
• ClinicalTrials.gov Identifier: NCT01155193
• Other Study ID Numbers: P10-410
• First Posted: Jul 1, 2010
• Last Update Posted: Oct 29, 2018
• Last Verified: Jul 1, 2017

• Keywords provided by AbbVie (prior sponsor, Abbott): Children; Pre-term infants; Congenital heart disease; Infection; Respiratory syncytial virus; Bronchopulmonary dysplasia (BPD); Chronic lung disease (CLD)
• Additional relevant MeSH terms: Respiratory Syncytial Virus Infections

Study Results

Participant Flow

Recruitment Details	Pre-term infants and children under 24 months with high-risk for respiratory syncytial virus (RSV) were enrolled between September 01 and June 30 during each RSV season from 2002 to 2016. The registry was conducted in Germany.
Pre-assignment Detail	Results were subdivided into four parts due to procedural changes including changes in the methods of study data reporting during the conduct of the study: Registry 02/03 - 06/07 Registry 07/08 Registry 08/09 Registry 09/10 - 15/16

Arm/Group Title	Palivizumab Registry 02/03 - 06/07	Palivizumab Registry 07/08	Palivizumab Registry 08/09	Palivizumab Registry 09/10 - 15/16
Arm/Group Description	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2002 until 30 June 2007.	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2007 to 30 June 2008.	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2008 to 30 June 2009.	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016.
Period Title: Overall Study
STARTED	10924	3818	2260	13802
COMPLETED	10686	3805	2248	13711
NOT COMPLETED	238	13	12	91

Baseline Characteristics

Arm/Group Title	Palivizumab Registry 02/03 - 06/07	Palivizumab Registry 07/08	Palivizumab Registry 08/09	Palivizumab Registry 09/10 - 15/16	Total
Arm/Group Description	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2002 to 30 June 2007.	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2007 to 30 June 2008.	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2008 to 30 June 2009.	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016.	Total of all reporting groups
Overall Participants	10686	3805	2248	12729	29468
Age, Customized (Count of Participants)
< 29 weeks	3582 33.5%	1173 30.8%	694 30.9%	3514 27.6%	8963 30.4%
29 to < 33 weeks	3385 31.7%	1161 30.5%	705 31.4%	4033 31.7%	9284 31.5%
33 to ≤ 35 weeks	1500 14%	578 15.2%	474 21.1%	3237 25.4%	5789 19.6%
> 35 weeks	481 4.5%	164 4.3%	375 16.7%	1945 15.3%	2965 10.1%
Missing	1738 16.3%	729 19.2%	0 0%	0 0%	2467 8.4%
Sex/Gender, Customized (Count of Participants)
Female	4901 45.9%	1737 45.7%	1019 45.3%	5707 44.8%	13364 45.4%
Male	5716 53.5%	2051 53.9%	1229 54.7%	7013 55.1%	16009 54.3%
Missing	69 0.6%	17 0.4%	0 0%	9 0.1%	95 0.3%
Birth Weight (Count of Participants)
< 1000 g	3283 30.7%	1101 28.9%	595 26.5%	2946 23.1%	7925 26.9%
1000 - 1499 g	2782 26%	965 25.4%	538 23.9%	3063 24.1%	7348 24.9%
1500 - 1999 g	1788 16.7%	659 17.3%	424 18.9%	2590 20.3%	5461 18.5%
≥ 2000 g	2595 24.3%	995 26.1%	691 30.7%	4130 32.4%	8411 28.5%
Missing	238 2.2%	85 2.2%	0 0%	0 0%	323 1.1%
Age at Start of Immunoprophylaxis (months) [Mean (Standard Deviation) ]
Registry 02/03 - 06/07	5.2 (4.0)	5.2 (4.0)
Registry 07/08	5.0 (4.0)	5.0 (4.0)
Registry 08/09	5.9 (4.9)	5.9 (4.9)
Registry 09/10 - 15/16	4.3 (3.6)	4.3 (3.6)
Risk Factors for RSV Complications (Count of Participants)
Premature birth (< 29 weeks GA)	3582 33.5%	1173 30.8%	694 30.9%	3514 27.6%	8963 30.4%
Premature birth (≤ 35 weeks GA)	8467 79.2%	2912 76.5%	1873 83.3%	10784 84.7%	24036 81.6%
Multiple births	2607 24.4%	922 24.2%	632 28.1%	3793 29.8%	7954 27%
Congenital heart disease	3001 28.1%	1283 33.7%	567 25.2%	3430 26.9%	8281 28.1%
Smoking in the family	1422 13.3%	482 12.7%	400 17.8%	2037 16%	4341 14.7%
Chronic lung disease	4179 39.1%	1330 35%	584 26%	2346 18.4%	8439 28.6%
Immunodeficiency	430 4%	167 4.4%	30 1.3%	171 1.3%	798 2.7%
Attending daycare	240 2.2%	109 2.9%	74 3.3%	361 2.8%	784 2.7%
Other children (< 12 years) in household	4440 41.5%	1682 44.2%	1115 49.6%	4899 38.5%	12136 41.2%
Family history of asthma	823 7.7%	304 8%	NA NaN	1128 8.9%	NA NaN
Family history of allergic rhinitis	1234 11.5%	450 11.8%	NA NaN	NA NaN	NA NaN
Family history of allergic eczema	713 6.7%	245 6.4%	NA NaN	NA NaN	NA NaN
Family history of atopy	NA NaN	NA NaN	346 15.4%	2039 16%	NA NaN
Cyanotic heart defect	NA NaN	NA NaN	123 5.5%	784 6.2%	NA NaN
Chronic lung disease therapy	NA NaN	NA NaN	281 12.5%	1803 14.2%	NA NaN
Treatment with oxygen at home	NA NaN	NA NaN	133 5.9%	763 6%	NA NaN
Neuromuscular impairment	NA NaN	NA NaN	120 5.3%	786 6.2%	NA NaN
Down syndrome (Trisomy 21)	NA NaN	NA NaN	NA NaN	249 2%	NA NaN
Serious neurological disease	NA NaN	NA NaN	NA NaN	428 3.4%	NA NaN
Low social status	NA NaN	NA NaN	NA NaN	2258 17.7%	NA NaN
Crowded living conditions	NA NaN	NA NaN	NA NaN	2592 20.4%	NA NaN
Exposition to air pollution	NA NaN	NA NaN	NA NaN	1710 13.4%	NA NaN
Breast feeding ≤ 2 months	NA NaN	NA NaN	NA NaN	5794 45.5%	NA NaN
Immunoprophylaxis with Palivizumab Started in Hospital (Count of Participants)
Count of Participants [Participants]	1645 15.4%	519 13.6%	313 13.9%	3127 24.6%	5604 19%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With RSV-associated Hospitalization
Time Frame	During RSV season (September to June) from 2002 to 2016

Outcome Measure Data

Analysis Population Description

Evaluable population with available hospitalization data

Arm/Group Title	Palivizumab Registry 02/03 - 06/07	Palivizumab Registry 07/08	Palivizumab Registry 08/09	Palivizumab Registry 09/10 - 15/16
Arm/Group Description	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2002 to 30 June 2007.	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2007 to 30 June 2008.	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2008 to 30 June 2009.	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016.
Measure Participants	9833	3805	2248	12729
Number [percentage of participants]	1.5 0%	1.5 0%	0.8 0%	0.7 0%

2. Secondary Outcome

Title	Diagnosis Documented at Hospital Discharge in Registries 02/03 - 06/07 and 07/08
Description	Hospitalization due to RSV was documented on a separate hospitalization form. The data below represent the number of hospitalizations documented on forms; some participants may have had more than one hospitalization. Multiple entries for discharge diagnosis were possible.
Time Frame	During RSV season (September to June) from 2002 to 2008

Outcome Measure Data

Analysis Population Description

Participants in registries 02/03 - 06/07 and 07/08 who were hospitalized, and hospitalization was documented on paper case report forms.

Arm/Group Title	Palivizumab Registry 02/03 - 06/07	Palivizumab Registry 07/08
Arm/Group Description	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2002 to 30 June 2007.	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2007 to 30 June 2008.
Measure Participants	324	107
Measure hospitalizations	334	121
Bronchiolitis	67	18
RSV-Bronchiolitis	99	34
Pneumonia (Viral pneumonia)	26	12
RSV-Pneumonia	44	14
RSV-Infection	49	26
Other	134	70
Any RSV diagnosis	154	57

3. Secondary Outcome

Title	Diagnosis Documented at Hospital Discharge in Registry 08/09 and 09/10 - 15/16
Description	In the season 2008/09, the eCRF system for data collection was introduced. Hospitalization due to RSV infection was documented on a separate hospitalization form in the electronic case report form (eCRF). Physicians were asked to specify a primary diagnosis at hospital discharge.
Time Frame	During RSV season (September to June) from 2008 to 2016

Outcome Measure Data

Analysis Population Description

Participants in registries 08/09 and 09/10 - 15/16 who were hospitalized, and hospitalization was documented on forms and with available diagnosis data (for registry 09/10 - 15/16)

Arm/Group Title	Palivizumab Registry 08/09	Registry 09/10 - 15/16 Hospitalization Associated With RSV	Registry 09/10 - 15/16 Hospitalizations Not RSV-Associated
Arm/Group Description	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2008 to 30 June 2009.	Participants who were prescribed palivizumab (Synagis®) prophylaxis according to the German SPC for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016, and had a hospitalization associated with RSV infection.	Participants who were prescribed palivizumab (Synagis®) prophylaxis according to the German SPC for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016, and had a hospitalization that was not associated with RSV infection.
Measure Participants	79	87	269
Measure hospitalizations	90	85	220
Bronchitis	24	24	115
Bronchiolitis	4	32	15
Pneumonia (clinical diagnosis)	7	9	27
Pneumonia (confirmed by chest radiography)	18	19	58
Acute respiratory failure	3	1	3
Apnoea-bradycardia syndrome	1	0	2
Not specified	33	0	0

4. Secondary Outcome

Title	Presence of Complications During Hospitalization
Time Frame	During RSV season (September to June) from 2002 to 2016

Outcome Measure Data

Analysis Population Description

Evaluable population who were hospitalized and with available hospitalization complication data

Arm/Group Title	Palivizumab Registry 02/03 - 06/07	Palivizumab Registry 07/08	Palivizumab Registry 08/09	Registry 09/10 - 15/16 Hospitalization Associated With RSV	Registry 09/10 - 15/16 Hospitalizations Not RSV-Associated
Arm/Group Description	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2002 until 30 June 2007.	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2007 to 30 June 2008.	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2008 to 30 June 2009.	Participants who were prescribed palivizumab (Synagis®) prophylaxis according to the German SPC for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016, and had a hospitalization that was associated with RSV infection.	Participants who were prescribed palivizumab (Synagis®) prophylaxis according to the German SPC for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016, and had a hospitalization that was not associated with RSV infection.
Measure Participants	324	107	79	87	269
Measure hospitalizations	334	121	90	92	356
Intensive care unit (ICU) admission	111	29	22	14	56
Oxygen supplementation required	177	54	42	58	160
Mechanical ventilation	44	11	8	6	34

5. Secondary Outcome

Title	Parental Cooperation in Registries 02/03 - 06/07 and 07/08
Description	Cooperation of parents with the prophylaxis regimen was categorized as very good, good, moderate, bad or very bad.
Time Frame	During RSV season (September to June) from 2002 to 2008

Outcome Measure Data

Analysis Population Description

Evaluable population in registries 02/03 - 06/07 and 07/08

Arm/Group Title	Palivizumab Registry 02/03 - 06/07	Palivizumab Registry 07/08
Arm/Group Description	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2002 to 30 June 2007.	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2007 to 30 June 2008.
Measure Participants	10686	3805
Very good/good	9383 87.8%	3340 87.8%
Moderate	567 5.3%	221 5.8%
Bad/very bad	354 3.3%	102 2.7%
Missing	382 3.6%	142 3.7%

6. Secondary Outcome

Title	Parental Cooperation for Registry 08/09 and 09/10 - 15/16
Description	Cooperation of parents with the prophylaxis regimen was evaluated per injection in registry 08/09 and 09/10 - 15/16. The categories for cooperation ratings were changed to good, satisfying, or bad: Good: all palivizumab doses could be administered as planned; Satisfying: a single palivizumab dose was missed by the parents; Bad: more than one palivizumab doses was missed by the parents.
Time Frame	During RSV season (September to June) from 2008 to 2016

Outcome Measure Data

Analysis Population Description

Evaluable population in in registries 08/09 and 09/10 - 15/16; for registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.

Arm/Group Title	Palivizumab Registry 08/09	Palivizumab Registry 09/10 - 15/16
Arm/Group Description	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2008 to 30 June 2009.	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016.
Measure Participants	2248	12729
Measure Palivizumab injections	11039	63572
Good	8175	51408
Satisfying	550	2985
Bad	143	575
Missing	2171	8604

7. Secondary Outcome

Title	Mean Number of Palivizumab Injections
Description	The mean number of palivizumab injections per participant, per season.
Time Frame	During RSV season (September to June) from 2002 to 2016

Outcome Measure Data

Analysis Population Description

Evaluable population; for registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.

Arm/Group Title	Palivizumab Registry 02/03 - 06/07	Palivizumab Registry 07/08	Palivizumab Registry 08/09	Palivizumab Registry 09/10 - 15/16
Arm/Group Description	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2002 to 30 June 2007.	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2007 to 30 June 2008.	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2008 to 30 June 2009.	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season from 01 September 2009 to 30 June 2016.
Measure Participants	10686	3805	2248	12729
Mean (Standard Deviation) [palivizumab injections]	4.7 (1.8)	4.8 (1.9)	4.9 (2.0)	5.0 (2.0)

Adverse Events

Time Frame	During RSV season (June to September) from 2002 to 2016
Adverse Event Reporting Description	Evaluable population includes participants who received their first palivizumab injection between 01 September and 31 May of a given season, and who were younger than 2 years at start of immunoprophylaxis. For registry 09/10 - 15/16 only participants who received their first immunoprophylaxis in the corresponding season are included.
Arm/Group Title	Palivizumab
Arm/Group Description	Participants were prescribed palivizumab (Synagis®) prophylaxis according to the German summary of product characteristics (SPC) for Synagis® to prevent serious disease due to RSV infection during the RSV season (September to June) from 2002 to 2016.
All Cause Mortality
	Palivizumab
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Palivizumab
	Affected / at Risk (%)	# Events
Total	701/29468 (2.4%)
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA	1/29468 (0%)
LEUKOCYTOSIS	3/29468 (0%)
LEUKOPENIA	1/29468 (0%)
THROMBOCYTOPENIA	1/29468 (0%)
Cardiac disorders
AORTIC VALVE STENOSIS	1/29468 (0%)
BRADYCARDIA	3/29468 (0%)
CARDIAC ARREST	2/29468 (0%)
CARDIAC DISORDER	2/29468 (0%)
CARDIAC FAILURE	2/29468 (0%)
CARDIOPULMONARY FAILURE	1/29468 (0%)
CARDIOVASCULAR INSUFFICIENCY	1/29468 (0%)
CYANOSIS	4/29468 (0%)
MYOCARDITIS	1/29468 (0%)
RESTRICTIVE CARDIOMYOPATHY	1/29468 (0%)
RIGHT VENTRICULAR DYSFUNCTION	1/29468 (0%)
Congenital, familial and genetic disorders
ATRIAL SEPTAL DEFECT	1/29468 (0%)
CONGENITAL CENTRAL HYPOVENTILATION SYNDROME	1/29468 (0%)
FALLOT'S TETRALOGY	1/29468 (0%)
HEART DISEASE CONGENITAL	2/29468 (0%)
HYPOPLASTIC LEFT HEART SYNDROME	1/29468 (0%)
LISSENCEPHALY	1/29468 (0%)
WOLF-HIRSCHHORN SYNDROME	1/29468 (0%)
Gastrointestinal disorders
ABDOMINAL PAIN	1/29468 (0%)
DIAPHRAGMATIC HERNIA	1/29468 (0%)
DIARRHOEA	3/29468 (0%)
FLATULENCE	1/29468 (0%)
GASTROOESOPHAGEAL REFLUX DISEASE	1/29468 (0%)
HAEMATOCHEZIA	1/29468 (0%)
INGUINAL HERNIA	1/29468 (0%)
INTESTINAL OBSTRUCTION	1/29468 (0%)
NECROTISING COLITIS	1/29468 (0%)
UMBILICAL HERNIA	1/29468 (0%)
VOMITING	4/29468 (0%)
General disorders
ADVERSE DRUG REACTION	6/29468 (0%)
ADVERSE EVENT	2/29468 (0%)
CARDIAC DEATH	1/29468 (0%)
DEATH	12/29468 (0%)
GENERAL PHYSICAL HEALTH DETERIORATION	12/29468 (0%)
HYPOTHERMIA	1/29468 (0%)
MALAISE	2/29468 (0%)
OEDEMA	1/29468 (0%)
PYREXIA	21/29468 (0.1%)
Immune system disorders
ANAPHYLACTIC REACTION	1/29468 (0%)
Infections and infestations
ADENOVIRAL UPPER RESPIRATORY INFECTION	1/29468 (0%)
BRONCHIOLITIS	31/29468 (0.1%)
BRONCHITIS	124/29468 (0.4%)
BRONCHITIS VIRAL	1/29468 (0%)
CELLULITIS	1/29468 (0%)
CONJUNCTIVITIS	3/29468 (0%)
DEVICE RELATED SEPSIS	1/29468 (0%)
EXANTHEMA SUBITUM	1/29468 (0%)
GASTROENTERITIS	7/29468 (0%)
GASTROENTERITIS NOROVIRUS	3/29468 (0%)
GASTROENTERITIS ROTAVIRUS	2/29468 (0%)
INFECTION	3/29468 (0%)
INFECTIVE PERICARDIAL EFFUSION	1/29468 (0%)
INFLUENZA	3/29468 (0%)
LARYNGOTRACHEITIS OBSTRUCTIVE	1/29468 (0%)
MYELITIS	1/29468 (0%)
NASOPHARYNGITIS	7/29468 (0%)
OSTEOMYELITIS	2/29468 (0%)
OTITIS MEDIA	3/29468 (0%)
PERTUSSIS	1/29468 (0%)
PNEUMONIA	105/29468 (0.4%)
PNEUMONIA BACTERIAL	1/29468 (0%)
PNEUMONIA ESCHERICHIA	1/29468 (0%)
PNEUMONIA INFLUENZAL	1/29468 (0%)
PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL	51/29468 (0.2%)
PNEUMONIA VIRAL	18/29468 (0.1%)
PSEUDOCROUP	4/29468 (0%)
RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS	85/29468 (0.3%)
RESPIRATORY SYNCYTIAL VIRUS BRONCHITIS	30/29468 (0.1%)
RESPIRATORY SYNCYTIAL VIRUS INFECTION	44/29468 (0.1%)
RESPIRATORY TRACT INFECTION	19/29468 (0.1%)
RESPIRATORY TRACT INFECTION VIRAL	3/29468 (0%)
SEPSIS	1/29468 (0%)
STAPHYLOCOCCAL INFECTION	1/29468 (0%)
SUPERINFECTION BACTERIAL	1/29468 (0%)
UPPER RESPIRATORY TRACT INFECTION	12/29468 (0%)
VIRAL INFECTION	5/29468 (0%)
Injury, poisoning and procedural complications
INJECTION RELATED REACTION	1/29468 (0%)
LOWER LIMB FRACTURE	1/29468 (0%)
Investigations
ANTIMICROBIAL SUSCEPTIBILITY TEST RESISTANT	1/29468 (0%)
BODY TEMPERATURE INCREASED	1/29468 (0%)
BREATH SOUNDS ABNORMAL	1/29468 (0%)
CATHETERISATION CARDIAC	1/29468 (0%)
INFLUENZA VIRUS TEST POSITIVE	1/29468 (0%)
OXYGEN SATURATION DECREASED	7/29468 (0%)
RESPIRATORY SYNCYTIAL VIRUS TEST POSITIVE	8/29468 (0%)
STAPHYLOCOCCUS TEST POSITIVE	1/29468 (0%)
WEIGHT DECREASED	2/29468 (0%)
Metabolism and nutrition disorders
DECREASED APPETITE	1/29468 (0%)
DEHYDRATION	3/29468 (0%)
DIET REFUSAL	6/29468 (0%)
FAILURE TO THRIVE	4/29468 (0%)
FLUID INTAKE REDUCED	7/29468 (0%)
LACTOSE INTOLERANCE	1/29468 (0%)
MALNUTRITION	2/29468 (0%)
METABOLIC ACIDOSIS	1/29468 (0%)
Musculoskeletal and connective tissue disorders
ARTHRITIS	1/29468 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HAEMANGIOMA	1/29468 (0%)
HISTIOCYTOSIS	1/29468 (0%)
Nervous system disorders
ALTERED STATE OF CONSCIOUSNESS	1/29468 (0%)
FEBRILE CONVULSION	5/29468 (0%)
HYDROCEPHALUS	3/29468 (0%)
INFANTILE SPASMS	2/29468 (0%)
SEIZURE	5/29468 (0%)
Pregnancy, puerperium and perinatal conditions
NEONATAL DISORDER	1/29468 (0%)
POOR WEIGHT GAIN NEONATAL	1/29468 (0%)
Psychiatric disorders
APATHY	1/29468 (0%)
RESTLESSNESS	2/29468 (0%)
Renal and urinary disorders
RENAL DISORDER	1/29468 (0%)
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME	1/29468 (0%)
ACUTE RESPIRATORY FAILURE	5/29468 (0%)
APNOEA	8/29468 (0%)
APPARENT LIFE THREATENING EVENT	1/29468 (0%)
ASPIRATION	2/29468 (0%)
ASTHMA	1/29468 (0%)
BRONCHIAL HYPERREACTIVITY	2/29468 (0%)
BRONCHIAL OBSTRUCTION	1/29468 (0%)
BRONCHITIS CHRONIC	1/29468 (0%)
BRONCHOPULMONARY DYSPLASIA	1/29468 (0%)
COUGH	13/29468 (0%)
DYSPNOEA	15/29468 (0.1%)
HYPERCAPNIA	2/29468 (0%)
HYPOXIA	2/29468 (0%)
INFANTILE APNOEA	3/29468 (0%)
IRREGULAR BREATHING	1/29468 (0%)
LARYNGEAL STENOSIS	1/29468 (0%)
NEONATAL HYPOXIA	1/29468 (0%)
OBSTRUCTIVE AIRWAYS DISORDER	3/29468 (0%)
PNEUMONIA ASPIRATION	1/29468 (0%)
PULMONARY HYPERTENSION	1/29468 (0%)
RALES	1/29468 (0%)
RESPIRATORY DISORDER	12/29468 (0%)
RESPIRATORY DISTRESS	1/29468 (0%)
RESPIRATORY FAILURE	16/29468 (0.1%)
SLEEP APNOEA SYNDROME	1/29468 (0%)
TACHYPNOEA	2/29468 (0%)
Skin and subcutaneous tissue disorders
ECZEMA INFANTILE	1/29468 (0%)
HYPERHIDROSIS	1/29468 (0%)
RASH	1/29468 (0%)
Surgical and medical procedures
CARDIAC OPERATION	7/29468 (0%)
ELECTIVE PROCEDURE	1/29468 (0%)
ENTEROSTOMY	1/29468 (0%)
HERNIA REPAIR	3/29468 (0%)
HOSPITALISATION	114/29468 (0.4%)
ILEOSTOMY CLOSURE	1/29468 (0%)
IMMUNISATION	1/29468 (0%)
OXYGEN SUPPLEMENTATION	9/29468 (0%)
PHARYNGEAL RECONSTRUCTION	1/29468 (0%)
PLASTIC SURGERY OF THE LIPS AND MOUTH	1/29468 (0%)
PULMONARY VALVE REPAIR	1/29468 (0%)
Vascular disorders
AORTIC STENOSIS	1/29468 (0%)
Other (Not Including Serious) Adverse Events
	Palivizumab
	Affected / at Risk (%)	# Events
Total	34/29468 (0.1%)
Blood and lymphatic system disorders
THROMBOCYTOPENIA	1/29468 (0%)
Cardiac disorders
CARDIOVASCULAR DISORDER	1/29468 (0%)
CYANOSIS	1/29468 (0%)
Congenital, familial and genetic disorders
HEART DISEASE CONGENITAL	1/29468 (0%)
Gastrointestinal disorders
DIARRHOEA	3/29468 (0%)
VOMITING	1/29468 (0%)
General disorders
ADMINISTRATION SITE REACTION	1/29468 (0%)
ADVERSE DRUG REACTION	2/29468 (0%)
ADVERSE EVENT	1/29468 (0%)
DRUG INEFFECTIVE	1/29468 (0%)
IRRITABILITY POSTVACCINAL	1/29468 (0%)
PERIPHERAL SWELLING	1/29468 (0%)
PYREXIA	6/29468 (0%)
VACCINATION SITE REACTION	1/29468 (0%)
Infections and infestations
BRONCHITIS	3/29468 (0%)
BRUCELLOSIS	1/29468 (0%)
INFECTION	1/29468 (0%)
RESPIRATORY SYNCYTIAL VIRUS BRONCHITIS	1/29468 (0%)
RESPIRATORY SYNCYTIAL VIRUS INFECTION	3/29468 (0%)
UPPER RESPIRATORY TRACT INFECTION	1/29468 (0%)
VIRAL INFECTION	1/29468 (0%)
Injury, poisoning and procedural complications
OVERDOSE	1/29468 (0%)
VACCINATION COMPLICATION	1/29468 (0%)
Metabolism and nutrition disorders
DECREASED APPETITE	1/29468 (0%)
DIET REFUSAL	1/29468 (0%)
FEEDING DISORDER	1/29468 (0%)
Psychiatric disorders
CONFUSIONAL STATE	1/29468 (0%)
PERSONALITY CHANGE	1/29468 (0%)
RESTLESSNESS	2/29468 (0%)
SCREAMING	1/29468 (0%)
Respiratory, thoracic and mediastinal disorders
BRONCHIAL OBSTRUCTION	1/29468 (0%)
DYSPNOEA	1/29468 (0%)
Skin and subcutaneous tissue disorders
ERYTHEMA	1/29468 (0%)
RASH	3/29468 (0%)
Surgical and medical procedures
HOSPITALISATION	1/29468 (0%)

Limitations/Caveats

[Not Specified]

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.