Respiratory Syncytial Virus InfectionNCT01537198

Surveillance of Synagis in Korean Pediatric Patients

An observational study of Respiratory Syncytial Virus Infection, run by AbbVie (prior sponsor, Abbott).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 1 day to 24 months
Conditions the study is for: Respiratory Syncytial Virus Infection
How many people: 618 participants
Where: No sites listed yet
Study dates: Jan 2012to Jun 2014
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 1 day to 24 months
All sexes
No healthy volunteers
Child

Study population: General hospital

Who may be able to join

Pediatric patients at high risk of RSV disease, who need the prevention of serious lower respiratory tract disease caused by RSV, and meet any of the following criteria:
Preterm newborn infants or infants born at 35 weeks of gestation or less, and less than 6 months of age at the onset of RSV season (RSV season defined as Oct. 1 to the following Mar. 31).
Newborn infants, infants, or children under 2 years of age and requiring treatment for bronchopulmonary dysplasia (BPD) within the last 6 months preceding RSV season (RSV season defined as Oct. 1 to the following Mar. 31).
Newborn infants, infants, or children under 2 years of age with hemodynamically significant congenital heart disease (CHD).
Obtained authorization form to use personal and/or health data from legal representative prior to the entry into the study.

Who cannot join

Contraindications according to the approved label.

About this study

Official title: Post-Marketing Surveillance of Synagis in Korean Pediatric Patients Under the "New Drug Re-Examination"

Approximately 600 pediatric patients prescribed palivizumab (Synagis) prophylaxis in usual practice according to the approved Korean product label will be registered into this observational study. Baseline data will be obtained at enrollment including demographics, gestational age, birth weight and underlying diseases and complications especially in regard to respiratory disease and cardiovascular disease. At routine visits for Synagis administration, which will occur according to usual medical practice, information on Synagis prophylaxis, concomitant medication, and adverse events will be collected for up to 30 days after the last administration of Synagis.

Conditions: Respiratory Syncytial Virus Infection
Keywords: Postmarketing Drug Surveillance
Medical subject headings: Respiratory Syncytial Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01537198
Study group	Role	What they receive
Pediatric Participants at High Risk of RSV		Pediatric participants at high risk of respiratory syncytial virus (RSV) in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant's enrollment in the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs)
An AE was defined as any untoward medical occurrence that did not necessarily have a causal relationship with treatment. An SAE was an event that resulted in death, was life-threatening, required or prolonged hospitalization, resulted in congenital anomaly or persistent or significant disability, important medical event requiring medical or surgical intervention to prevent serious outcome, or a spontaneous or elective abortion. AEs considered to be related to Synagis were classified as ADRs. The causality of ADRs were assessed by the investigator as 'Probable,' 'Possible' and 'others (unknown). 'Unexpected' AEs are those that are unlabeled.
Measured: From the time of informed consent until 30 days after the final administration of Synagis, an expected average of 6 months from the start of Synagis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Jun 2014

First posted23 Feb 2012 (estimated)
Study startJan 2012
Primary completionJun 2014
Study completionJun 2014

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.
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: Case only
Time perspective: Prospective
Enrolment: 618 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01537198
Sponsor's protocol ID: P13-203
Status last verified: Jun 2015
First submitted: 15 Dec 2011
Last updated: 10 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Respiratory Syncytial Virus Infections
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
RecruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization

All Respiratory Syncytial Virus Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-Marketing Surveillance of Synagis in Korean Pediatric Patients Under the "New Drug Re-Examination"
ClinicalTrials.gov ID: NCT01537198
Acronym / sponsor ID: P13-203
Conditions: Respiratory Syncytial Virus Infection
Keywords: Postmarketing Drug Surveillance
Study type: Observational
Recruitment status: Completed
Enrolment: 618 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 23 Feb 2012 (estimated)
Results: Posted 10 Jul 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Pediatric Participants at High Risk of RSV	–	–Pediatric participants at high risk of respiratory syncytial virus (RSV) in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant's enrollment in the study.

Who may qualify

Ages: 1 day to 24 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: General hospital

Key inclusion criteria (5 listed)

Pediatric patients at high risk of RSV disease, who need the prevention of serious lower respiratory tract disease caused by RSV, and meet any of the following criteria:
Obtained authorization form to use personal and/or health data from legal representative prior to the entry into the study.

Key exclusion criteria (1 listed)

Contraindications according to the approved label.

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 Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs)
Time frame: From the time of informed consent until 30 days after the final administration of Synagis, an expected average of 6 months from the start of Synagis
An AE was defined as any untoward medical occurrence that did not necessarily have a causal relationship with treatment. An SAE was an event that resulted in death, was life-threatening, required or prolonged hospitalization, resulted in congenital anomaly or persistent or significant disability, important medical event requiring medical or surgical intervention to prevent serious outcome, or a spontaneous or elective abortion. AEs considered to be related to Synagis were classified as ADRs. The causality of ADRs were assessed by the investigator as 'Probable,' 'Possible' and 'others (unknown). 'Unexpected' AEs are those that are unlabeled.

Results and safety

Results posted to the registry on 10 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pediatric Participants at High Risk of RSV	617	463

Primary outcome: Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs)

Time frame: From the time of informed consent until 30 days after the final administration of Synagis, an expected average of 6 months from the start of Synagis. Number. Unit: participants

Measure	Pediatric Participants at High Risk of RSV n = 617
Any AE	126
Any ADR	3
Any SAE	46
Any serious ADR	3
Any unexpected AE	67
Any unexpected ADR	0

Adverse events

Time frame: From the time of informed consent until 30 days after the final administration of Synagis, an expected average of 6 months from the start of Synagis. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pediatric Participants at High Risk of RSV	46 of 617 (7.5%)	32 of 617 (5.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Respiratory Syncytial Virus Infection

RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Respiratory Syncytial Virus Infections
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
RecruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization

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.

SoRa Lee, MD study director

AbbVie

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Syncytial Virus Infection, run by AbbVie (prior sponsor, Abbott).

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 5 inclusion and 1 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 10 Jul 2015. 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 10 Jul 2015). 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 Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs) (time frame: From the time of informed consent until 30 days after the final administration of Synagis, an expected average of 6 months from the start of Synagis). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01537198.

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 10 Jul 2015.