Respiratory Syncytial Virus InfectionNCT02016690
Synagis® Liquid 50mg, 100mg for Intramuscular Injection Special Investigation in Immunocompromised Children With Synagis®
An observational study of Respiratory Syncytial Virus Infection, run by AbbVie.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Respiratory Syncytial Virus Infection
- How many people
- 312 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Dec 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Single-arm, Multi-center, Prospective Cohort
Who may be able to join
- 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
Show all 13Show fewer
- 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.
Who cannot join
- 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
About this study
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.
Read the detailed description
Palivizumab was prescribed according to the local label and independently of the decision to enroll participants in the study. Palivizumab was administered monthly throughout the Respiratory Syncytial Virus (RSV) infection seasons via intramuscular injection at a dose of 15 mg/kg of body weight. Survey forms were collected after the observation period. The number of adverse events and the frequency of hospitalizations due to RSV infections in surveyed participants were assessed to evaluate the safety and effectiveness of palivizumab.
- Conditions
- Respiratory Syncytial Virus Infection
- Keywords
- Prevention of severe RSV infection, Respiratory syncytial virus (RSV) infection, Down Syndrome, Immunocompromised, Effectiveness of palivizumab
- Medical subject headings
- Respiratory Syncytial Virus Infections, Infections, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Immunocompromised children | Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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
The Lower Respiratory Tract Infection (LRI) Score ranged from 0 (well or baseline); 1 (Upper Respiratory tract Infection [URI]), mild); 2 (LRI); 3 (LRI, moderate); 4 (LRI, severe) to 5 (Respiratory Failure). Components of the score included respiratory rate per minute, oxygen saturation, and physical findings of LRI. LRI scores were documented on the case report form (CRF).
Measured: 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
Hospitalization due to RSV infection or the presence/absence of positive RSV antigen test results during hospitalization was documented on the case report form (CRF).
Measured: 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
The date of hospitalization due to RSV infection and the date of hospital discharge were documented on the case report form (CRF).
Measured: 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
The presence/absence of respiratory support, (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) the start and end dates of respiratory support, and the dates of hospitalization and discharge were documented on the case report form (CRF).
Measured: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Mean Duration of Respiratory Support
The presence/absence of respiratory support (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) and the start and end dates of respiratory support were documented on the case report form (CRF).
Measured: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Syncytial Virus InfectionStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Osamu Mikami, MD, PhD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016690
- Sponsor's protocol ID
- P14-296
- Status last verified
- Feb 2017
- First submitted
- 11 Dec 2013
- Last updated
- 20 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synagis® Liquid 50mg, 100mg for Intramuscular Injection Special Investigation in Immunocompromised Children With Synagis®
- ClinicalTrials.gov ID
- NCT02016690
- Acronym / sponsor ID
- P14-296
- Conditions
- Respiratory Syncytial Virus Infection
- Keywords
- Prevention of severe RSV infection, Respiratory syncytial virus (RSV) infection, Down Syndrome, Immunocompromised, Effectiveness of palivizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Posted 8 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Palivizumab was prescribed according to the local label and independently of the decision to enroll participants in the study. Palivizumab was administered monthly throughout the Respiratory Syncytial Virus (RSV) infection seasons via intramuscular injection at a dose of 15 mg/kg of body weight. Survey forms were collected after the observation period. The number of adverse events and the frequency of hospitalizations due to RSV infections in surveyed participants were assessed to evaluate the safety and effectiveness of palivizumab.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunocompromised children | – | –Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Single-arm, Multi-center, Prospective Cohort
Key inclusion criteria (13 listed)
- 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:
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Adverse Events
Time frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
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).
Number of Participants With Serious Adverse Events
Time frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
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).
Number of Participants With Adverse Drug Reactions
Time frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
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).
5 secondary outcomes
Change in Lower Respiratory Tract Infection (LRI) Score During the Study
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Mean Duration of Respiratory Support
Time frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osamu Mikami, MD, PhD study director
AbbVie
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus Infection, run by AbbVie.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.