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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01006629

Enrollment

100

Registered

2009-11-03

Start date

2009-11-30

Completion date

2010-07-31

Last updated

2011-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Syncytial Virus Infection, Premature Birth, Bronchopulmonary Dysplasia, Congenital Heart Disease

Keywords

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

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.

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 \[HSCHD\]).

Interventions

BIOLOGICALpalivizumab

palivizumab 15 mg/kg intramuscularly

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 2 Years

Healthy volunteers

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. 2. 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.

Design outcomes

Primary

Measure	Time frame	Description
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.
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

Measure	Time frame	Description
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.
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.
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.
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.
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.
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.

Countries

Russia

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.

Participants by arm

Arm	Count
Palivizumab palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections	100
Total	100

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	1
Overall Study	Parent refused to continue participation	1
Overall Study	Parent unable to perform site visit	4

Baseline characteristics

Characteristic	Palivizumab
Age Continuous	8.2 months STANDARD_DEVIATION 6.3
Age, Customized Between 0 and 3 months	28 participants
Age, Customized Between 10 and 12 months	7 participants
Age, Customized Between 13 and 15 months	8 participants
Age, Customized Between 16 and 18 months	10 participants
Age, Customized Between 19 and 21 months	5 participants
Age, Customized Between 22 and 24 months	4 participants
Age, Customized Between 4 and 6 months	24 participants
Age, Customized Between 7 and 9 months	14 participants
Gestational Age	33.4 weeks STANDARD_DEVIATION 5.1
Gestational Age, categorical Between 29 and 32 weeks gestational age	22 participants
Gestational Age, categorical Between 33 and 35 weeks gestational age	22 participants
Gestational Age, categorical Greater than 35 weeks gestational age	33 participants
Gestational Age, categorical Less than 29 weeks gestational age	23 participants
Infants <= 24 months of age at enrollment and with a diagnosis of BPD No	54 participants
Infants <= 24 months of age at enrollment and with a diagnosis of BPD Yes	46 participants
Infants <= 24 months of age at enrollment and with HSCHD No	70 participants
Infants <= 24 months of age at enrollment and with HSCHD Yes	30 participants
Infants born <= 35 weeks gestational age and <= 6 months of age at enrollment No	67 participants
Infants born <= 35 weeks gestational age and <= 6 months of age at enrollment Yes	33 participants
Region of Enrollment Russian Federation	100 participants
Sex: Female, Male Female	52 Participants
Sex: Female, Male Male	48 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	39 / 100
serious Total, serious adverse events	10 / 100

Outcome results

Primary

Frequency of Adverse Events

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.