Trial Outcomes & Findings for Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children (NCT NCT01006629)

NCT ID: NCT01006629

Last Updated: 2011-07-19

Results Overview

Number of subjects experiencing an RSV hospitalization

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 100 participants
• Primary outcome timeframe: Through 30 days following the last injection of palivizumab
• Results posted on: 2011-07-19

Participant Flow

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.

Participant milestones

Measure	Palivizumab palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
Overall Study STARTED	100
Overall Study COMPLETED	94
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Palivizumab palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
Overall Study Adverse Event	1
Overall Study Parent refused to continue participation	1
Overall Study Parent unable to perform site visit	4

Baseline Characteristics

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

Baseline characteristics by cohort

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

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Palivizumab n=100 Participants palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
Frequency of Adverse Events	41 participants

PRIMARY outcome

Timeframe: Through 30 days following the last injection of palivizumab

Number of subjects experiencing an RSV hospitalization

Outcome measures

Measure	Palivizumab n=100 Participants palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
Number of Hospitalizations Due to Respiratory Syncytial Virus (RSV)	0 participants Interval 0.0 to 3.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Palivizumab

Serious events: 10 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Measure	Palivizumab n=100 participants at risk palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
Cardiac disorders Supraventricular tachycardia	1.0% 1/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Gastrointestinal disorders Enteritis	3.0% 3/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Infections and infestations Bronchitis	4.0% 4/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Infections and infestations Pneumonia	1.0% 1/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Infections and infestations Tonsillitis	1.0% 1/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Infections and infestations Upper respiratory tract infection	1.0% 1/100 • From date of first dose of study drug through 100 days after the last dose of study drug

Other adverse events

Measure	Palivizumab n=100 participants at risk palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
Cardiac disorders Arrhythmia	1.0% 1/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Eye disorders Glaucoma	1.0% 1/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Gastrointestinal disorders Anal stenosis	1.0% 1/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Gastrointestinal disorders Enteritis	1.0% 1/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Gastrointestinal disorders Teething	2.0% 2/100 • From date of first dose of study drug through 100 days after the last dose of study drug
General disorders Pyrexia	1.0% 1/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Immune system disorders Food allergy	1.0% 1/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Infections and infestations Ascariasis	1.0% 1/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Infections and infestations Bronchiolitis	1.0% 1/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Infections and infestations Bronchitis	3.0% 3/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Infections and infestations Dacryocystitis	1.0% 1/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Infections and infestations Ear infection	2.0% 2/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Infections and infestations Gastroenteritis	1.0% 1/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Infections and infestations Gastrointestinal infection	1.0% 1/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Infections and infestations Nasopharyngitis	2.0% 2/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Infections and infestations Pharyngitis	1.0% 1/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Infections and infestations Respiratory tract infection	2.0% 2/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Infections and infestations Respiratory tract infection viral	2.0% 2/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Infections and infestations Rhinitis	19.0% 19/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Infections and infestations Upper respiratory tract infection	8.0% 8/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Injury, poisoning and procedural complications Thermal burn	1.0% 1/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Investigations Blood pressure increased	1.0% 1/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Psychiatric disorders Nervousness	2.0% 2/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Respiratory, thoracic and mediastinal disorders Bronchopulmonary dysplasia	3.0% 3/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.0% 1/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	1.0% 1/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Skin and subcutaneous tissue disorders Dermatitis allergic	1.0% 1/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Skin and subcutaneous tissue disorders Dermatitis atopic	2.0% 2/100 • From date of first dose of study drug through 100 days after the last dose of study drug
Skin and subcutaneous tissue disorders Dermatitis contact	1.0% 1/100 • From date of first dose of study drug through 100 days after the last dose of study drug

Additional Information

Global Medical Services

Abbott

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER