Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01006629
• Collaborator: (none)
• Enrollment: 100
• Locations: 19
• Arm: 1
• Duration (Months): 8
• Patients Per Site: 5.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial virus (RSV) infection in order to study the safety and efficacy of the drug in Russian subjects.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus Infection; Premature Birth; Bronchopulmonary Dysplasia; Congenital Heart Disease	Biological: palivizumab	Phase 2/Phase 3

Detailed Description

A prospective, multicenter, open-label, non-comparative study of safety and efficacy of palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe lower respiratory tract respiratory syncytial virus infection in 100 Russian children of 2 years of age and less in high-risk populations (preterm infants [less than or equal to 35 weeks gestational age], infants with bronchopulmonary dysplasia [BPD], and infants with hemodynamically significant congenital heart disease [HSCHD]).

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Prospective, Multicenter, Open-label, Non-comparative Study of Safety and Efficacy of Synagis in Children at High Risk of Severe Respiratory Syncytial Virus Infection in the Russian Federation
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: palivizumab palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections	Biological: palivizumab; palivizumab 15 mg/kg intramuscularly; Other Names: ABT-315 (MEDI-493) Synagis 15 mg/kg intramuscularly

Outcome Measures

Primary Outcome Measures

1. Frequency of Adverse Events [Through 30 days following the last injection of palivizumab]

   Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 and 100 days after the last dose of study drug. The number of subjects experiencing a serious or nonserious treatment-emergent adverse event within 30 days after the last dose of study drug is summarized. See the Reported Adverse Events section for details.

2. Number of Hospitalizations Due to Respiratory Syncytial Virus (RSV) [Through 30 days following the last injection of palivizumab]

   Number of subjects experiencing an RSV hospitalization

Secondary Outcome Measures

1. Total Number of RSV Hospitalization Days [Through 30 days following the last injection of palivizumab]

   All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.

2. Total RSV Hospitalization Days With Increased Supplemental Oxygen Requirement [Through 30 days following the last injection of palivizumab]

   All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.

3. Number of Intensive Care Unit (ICU) Admissions During RSV Hospitalization [Through 30 days following the last injection of palivizumab]

   Outcome measure refers to the number of subjects admitted to the ICU during RSV hospitalization. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.

4. Total Days of RSV ICU Stay [Through 30 days following the last injection of palivizumab]

   All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.

5. Number of Subjects Who Received Mechanical Ventilation During RSV Hospitalization [Through 30 days following the last injection of palivizumab]

   All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.

6. Total Days of Mechanical Ventilation During RSV Hospitalization [Through 30 days following the last injection of palivizumab]

   All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 2 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Subjects must meet all of the following criteria to be enrolled into the study:

1. Infants at high risk of severe RSV infection defined as fulfilling at least one of the following:

• Infants born at less than or equal to 35 weeks gestational age AND are less than or equal to 6 months of age at enrollment

• Infants less than or equal to 24 months of age at enrollment AND with a diagnosis of bronchopulmonary dysplasia (defined as oxygen requirement at a corrected gestational age of 36 weeks) requiring intervention/management (i.e., oxygen, diuretics, bronchodilators, corticosteroids, etc.) anytime within 6 months prior to enrollment

• Infants less than or equal to 24 months of age at enrollment with hemodynamically significant congenital heart disease, either cyanotic or acyanotic, unoperated or partially corrected. Children with acyanotic cardiac lesions must have pulmonary hypertension (greater than or equal to 40 mmHg measured pressure in the pulmonary artery [ultrasound acceptable]) or the need for daily medication to manage congenital heart disease. Children with the following conditions are not eligible: hemodynamically insignificant small atrial or ventricular septal defects, patent ductus arteriosis, children with aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone.

1. Informed Consent Form signed by parent(s).

Exclusion Criteria:

Subjects meeting any of the following criteria are not eligible for the study:

1. Hospitalization at the time of enrollment (unless discharge is anticipated within 14 days).

2. Mechanical ventilation (including continuous positive airway pressure [CPAP]) at the time of enrollment.

3. Life expectancy less than 6 months.

4. Active respiratory illness, or other acute infection.

5. Known renal impairment, as determined by the investigator.

6. Known hepatic impairment, as determined by the investigator.

7. History of seizures (except neonatal seizures).

8. Unstable neurological disorder (includes, but is not restricted to, epilepsy and decompensated hydrocephaly).

9. Known immunodeficiency, as determined by the investigator.

10. Allergy to immunoglobulin products.

11. Prior receipt of RSV vaccine or prophylaxis (e.g., palivizumab or motavizumab), or administration of a product possibly containing RSV-neutralizing antibody within 100 days prior to enrollment (includes, but is not restricted to, the following: RSV hyperimmunoglobulin, polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin, varicella zoster hyperimmunoglobulin).

12. Participation in another clinical trial within 30 days prior to enrollment.

13. Previous enrollment in this trial.

14. For any reason, subject is considered by the investigator to be an unsuitable candidate for this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Ref # / Investigator 22699	Ivanovo		Russian Federation	153731
2	Site Ref # / Investigator 22694	Kazan		Russian Federation	420012
3	Site Ref # / Investigator 24022	Moscow		Russian Federation	117198
4	Site Ref # / Investigator 15744	Moscow		Russian Federation	117931
5	Site Ref # / Investigator 15745	Moscow		Russian Federation	117997
6	Site Ref # / Investigator 24025	Moscow		Russian Federation	117997
7	Site Ref # / Investigator 15781	Moscow		Russian Federation	119991
8	Site Ref # / Investigator 22686	Moscow		Russian Federation	119991
9	Site Ref # / Investigator 15747	Moscow		Russian Federation	125412
10	Site Ref # / Investigator 22696	Novosibirsk		Russian Federation	630091
11	Site Ref # / Investigator 24023	Novosibirsk		Russian Federation	630091
12	Site Ref # / Investigator 22692	Saint Petersburg		Russian Federation	193312
13	Site Ref # / Investigator 22683	Saint Petersburg		Russian Federation	194100
14	Site Ref # / Investigator 22693	Saint Petersburg		Russian Federation	194291
15	Site Ref # / Investigator 22685	Saint Petersburg		Russian Federation	196650
16	Site Ref # / Investigator 15722	Saint Petersburg		Russian Federation	197022
17	Site Ref # / Investigator 15748	Saint Petersburg		Russian Federation	198205
18	Site Ref # / Investigator 15782	Saint Petersburg		Russian Federation	198205
19	Site Ref # / Investigator 15746	Tomsk		Russian Federation	634012

Sponsors and Collaborators

• Abbott

Investigators

• Study Director: Konstantin M Gudkov, MD, Abbott

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01006629
• Other Study ID Numbers: W10-664
• First Posted: Nov 3, 2009
• Last Update Posted: Jul 19, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: Efficacy of palivizumab; Respiratory syncytial virus (RSV) infection; Prevention of severe RSV infection; Preterm infants; Infants with bronchopulmonary dysplasia; Infants with hemodynamically significant congenital heart disease
• Additional relevant MeSH terms: Infections; Communicable Diseases; Virus Diseases; Respiratory Syncytial Virus Infections; Bronchopulmonary Dysplasia; Premature Birth; Heart Diseases; Heart Defects, Congenital; Palivizumab

Study Results

Participant Flow

Recruitment Details	Subjects were enrolled into the study in 3 geographic areas of the Russian Federation. Recruitment began in November 2009 and ended in December 2009. Subjects at high risk of severe RSV infection (including preterm infants, infants with BPD, and infants with HSCHD) were identified as candidates for the study on the basis of routine assessments.

Arm/Group Title	Palivizumab
Arm/Group Description	palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
Period Title: Overall Study
STARTED	100
COMPLETED	94
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Palivizumab
Arm/Group Description	palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
Overall Participants	100
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	8.2 (6.3)
Age, Customized (participants) [Number]
Between 0 and 3 months	28 28%
Between 4 and 6 months	24 24%
Between 7 and 9 months	14 14%
Between 10 and 12 months	7 7%
Between 13 and 15 months	8 8%
Between 16 and 18 months	10 10%
Between 19 and 21 months	5 5%
Between 22 and 24 months	4 4%
Sex: Female, Male (Count of Participants)
Female	52 52%
Male	48 48%
Region of Enrollment (participants) [Number]
Russian Federation	100 100%
Gestational Age (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	33.4 (5.1)
Gestational Age, categorical (participants) [Number]
Less than 29 weeks gestational age	23 23%
Between 29 and 32 weeks gestational age	22 22%
Between 33 and 35 weeks gestational age	22 22%
Greater than 35 weeks gestational age	33 33%
Infants born <= 35 weeks gestational age and <= 6 months of age at enrollment (participants) [Number]
Yes	33 33%
No	67 67%
Infants <= 24 months of age at enrollment and with a diagnosis of BPD (participants) [Number]
Yes	46 46%
No	54 54%
Infants <= 24 months of age at enrollment and with HSCHD (participants) [Number]
Yes	30 30%
No	70 70%

Outcome Measures

1. Primary Outcome

Title	Frequency of Adverse Events
Description	Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 and 100 days after the last dose of study drug. The number of subjects experiencing a serious or nonserious treatment-emergent adverse event within 30 days after the last dose of study drug is summarized. See the Reported Adverse Events section for details.
Time Frame	Through 30 days following the last injection of palivizumab

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palivizumab
Arm/Group Description	palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
Measure Participants	100
Number [participants]	41 41%

2. Primary Outcome

Title	Number of Hospitalizations Due to Respiratory Syncytial Virus (RSV)
Description	Number of subjects experiencing an RSV hospitalization
Time Frame	Through 30 days following the last injection of palivizumab

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palivizumab
Arm/Group Description	palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
Measure Participants	100
Number (95% Confidence Interval) [participants]	0 0%

3. Secondary Outcome

Title	Total Number of RSV Hospitalization Days
Description	All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.
Time Frame	Through 30 days following the last injection of palivizumab

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palivizumab
Arm/Group Description	palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
Measure Participants	0

4. Secondary Outcome

Title	Total RSV Hospitalization Days With Increased Supplemental Oxygen Requirement
Description	All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.
Time Frame	Through 30 days following the last injection of palivizumab

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palivizumab
Arm/Group Description	palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
Measure Participants	0

5. Secondary Outcome

Title	Number of Intensive Care Unit (ICU) Admissions During RSV Hospitalization
Description	Outcome measure refers to the number of subjects admitted to the ICU during RSV hospitalization. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.
Time Frame	Through 30 days following the last injection of palivizumab

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palivizumab
Arm/Group Description	palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
Measure Participants	0

6. Secondary Outcome

Title	Total Days of RSV ICU Stay
Description	All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.
Time Frame	Through 30 days following the last injection of palivizumab

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palivizumab
Arm/Group Description	palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
Measure Participants	0

7. Secondary Outcome

Title	Number of Subjects Who Received Mechanical Ventilation During RSV Hospitalization
Description	All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.
Time Frame	Through 30 days following the last injection of palivizumab

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palivizumab
Arm/Group Description	palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
Measure Participants	0

8. Secondary Outcome

Title	Total Days of Mechanical Ventilation During RSV Hospitalization
Description	All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.
Time Frame	Through 30 days following the last injection of palivizumab

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palivizumab
Arm/Group Description	palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
Measure Participants	0

Adverse Events

Time Frame	From date of first dose of study drug through 100 days after the last dose of study drug
Arm/Group Title	Palivizumab
Arm/Group Description	palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
All Cause Mortality
	Palivizumab
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Palivizumab
	Affected / at Risk (%)	# Events
Total	10/100 (10%)
Cardiac disorders
Supraventricular tachycardia	1/100 (1%)
Gastrointestinal disorders
Enteritis	3/100 (3%)
Infections and infestations
Bronchitis	4/100 (4%)
Pneumonia	1/100 (1%)
Tonsillitis	1/100 (1%)
Upper respiratory tract infection	1/100 (1%)
Other (Not Including Serious) Adverse Events
	Palivizumab
	Affected / at Risk (%)	# Events
Total	39/100 (39%)
Cardiac disorders
Arrhythmia	1/100 (1%)
Eye disorders
Glaucoma	1/100 (1%)
Gastrointestinal disorders
Anal stenosis	1/100 (1%)
Enteritis	1/100 (1%)
Teething	2/100 (2%)
General disorders
Pyrexia	1/100 (1%)
Immune system disorders
Food allergy	1/100 (1%)
Infections and infestations
Ascariasis	1/100 (1%)
Bronchiolitis	1/100 (1%)
Bronchitis	3/100 (3%)
Dacryocystitis	1/100 (1%)
Ear infection	2/100 (2%)
Gastroenteritis	1/100 (1%)
Gastrointestinal infection	1/100 (1%)
Nasopharyngitis	2/100 (2%)
Pharyngitis	1/100 (1%)
Respiratory tract infection	2/100 (2%)
Respiratory tract infection viral	2/100 (2%)
Rhinitis	19/100 (19%)
Upper respiratory tract infection	8/100 (8%)
Injury, poisoning and procedural complications
Thermal burn	1/100 (1%)
Investigations
Blood pressure increased	1/100 (1%)
Psychiatric disorders
Nervousness	2/100 (2%)
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia	3/100 (3%)
Rhinorrhoea	1/100 (1%)
Tonsillar hypertrophy	1/100 (1%)
Skin and subcutaneous tissue disorders
Dermatitis allergic	1/100 (1%)
Dermatitis atopic	2/100 (2%)
Dermatitis contact	1/100 (1%)

Limitations/Caveats

This study had no control group; relative comparisons are only possible with current product information for palivizumab. No RSV hospitalizations occurred during the study; therefore, secondary outcome measures could not be evaluated.

More Information

Certain Agreements

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

Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.