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

NCT02016690 | Completed Results

• 1 other identifier: P14-296
• Study Type: observational
• Target: 312
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Syncytial Virus Infection

Keywords

Prevention of severe RSV infection; Respiratory syncytial virus (RSV) infection; Down Syndrome; Immunocompromised; Effectiveness of palivizumab

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Adverse Events

  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).

  From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks

• Number of Participants With Serious Adverse Events

  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).

  From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks

• Number of Participants With Adverse Drug Reactions

  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).

  From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks

Secondary Outcomes (5)

• 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

• 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

• 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

• 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

• Mean Duration of Respiratory Support

  From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks

Study Arms (1)

Immunocompromised children

Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Single-arm, Multi-center, Prospective Cohort

You may qualify if:

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

You may not qualify if:

• Participants included in the Contraindications section of the package insert
• Participants with known hypersensitivity to the ingredients of palivizumab
• Participants with a known positive RSV infection before hospitalization

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related Info

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections; Infections; Down Syndrome

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Limitations and 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.

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• Osamu Mikami, MD, PhD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: December 20, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 20, 2017
• Results First Posted: February 8, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share