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Respiratory Syncytial Virus InfectionPhase 2/3NCT01006629

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

A Phase 2/3 study testing palivizumab in people with Respiratory Syncytial Virus Infection and Premature Birth, run by Abbott at 19 sites in Russia.

Completed

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

Official record
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Trial 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… Read more about this study

Who is it for?
Ages Up to 2 years
What is being tested?
palivizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
19 sitesRussia
Study dates
Nov 2009to Jul 2010
Phase
Phase 2/3
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 2 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Subjects must meet all of the following criteria to be enrolled into the study:
  • 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.
  • Informed Consent Form signed by parent(s).

Who cannot join

  • Subjects meeting any of the following criteria are not eligible for the study:
  • Hospitalization at the time of enrollment (unless discharge is anticipated within 14 days).
  • Mechanical ventilation (including continuous positive airway pressure [CPAP]) at the time of enrollment.
  • Life expectancy less than 6 months.
  • Active respiratory illness, or other acute infection.
  • Known renal impairment, as determined by the investigator.
Show all 15Show fewer
  • Known hepatic impairment, as determined by the investigator.
  • History of seizures (except neonatal seizures).
  • Unstable neurological disorder (includes, but is not restricted to, epilepsy and decompensated hydrocephaly).
  • Known immunodeficiency, as determined by the investigator.
  • Allergy to immunoglobulin products.
  • 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).
  • Participation in another clinical trial within 30 days prior to enrollment.
  • Previous enrollment in this trial.
  • For any reason, subject is considered by the investigator to be an unsuitable candidate for this study.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Russia19 sites

  • Site Ref # / Investigator 22699

    Ivanovo, 153731

  • Site Ref # / Investigator 22694

    Kazan', 420012

  • Site Ref # / Investigator 24022

    Moscow, 117198

  • Site Ref # / Investigator 15744

    Moscow, 117931

  • Site Ref # / Investigator 15745

    Moscow, 117997

  • Site Ref # / Investigator 24025

    Moscow, 117997

  • Site Ref # / Investigator 15781

    Moscow, 119991

  • Site Ref # / Investigator 22686

    Moscow, 119991

  • Site Ref # / Investigator 15747

    Moscow, 125412

  • Site Ref # / Investigator 22696

    Novosibirsk, 630091

  • Site Ref # / Investigator 24023

    Novosibirsk, 630091

  • Site Ref # / Investigator 22692

    Saint Petersburg, 193312

  • Site Ref # / Investigator 22683

    Saint Petersburg, 194100

  • Site Ref # / Investigator 22693

    Saint Petersburg, 194291

  • Site Ref # / Investigator 22685

    Saint Petersburg, 196650

  • Site Ref # / Investigator 15722

    Saint Petersburg, 197022

  • Site Ref # / Investigator 15748

    Saint Petersburg, 198205

  • Site Ref # / Investigator 15782

    Saint Petersburg, 198205

  • Site Ref # / Investigator 15746

    Tomsk, 634012

Other trials in Russia

About this study

Official title: 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

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.

Read the 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]).

Being tested
palivizumab
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
Medical subject headings
Respiratory Syncytial Virus Infections, Premature Birth, Bronchopulmonary Dysplasia, Heart Defects, Congenital, Infections

What participants receive

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

  • palivizumabBiological

    Also called ABT-315 (MEDI-493), Synagis 15 mg/kg intramuscularly

    palivizumab 15 mg/kg intramuscularly

Study groups in NCT01006629
Study groupRoleWhat they receive
palivizumabExperimentalpalivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
Receives: Biological: palivizumab

What is being measured

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

  1. 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.

    Measured: Through 30 days following the last injection of palivizumab

  2. Number of Hospitalizations Due to Respiratory Syncytial Virus (RSV)

    Number of subjects experiencing an RSV hospitalization

    Measured: Through 30 days following the last injection of palivizumab

Secondary outcomes (6)

  1. Total Number of RSV Hospitalization Days

    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.

    Measured: Through 30 days following the last injection of palivizumab

  2. Total RSV Hospitalization Days With Increased Supplemental Oxygen Requirement

    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.

    Measured: Through 30 days following the last injection of palivizumab

  3. Number of Intensive Care Unit (ICU) Admissions During RSV Hospitalization

    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.

    Measured: Through 30 days following the last injection of palivizumab

  4. Total Days of RSV ICU Stay

    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.

    Measured: Through 30 days following the last injection of palivizumab

  5. Number of Subjects Who Received Mechanical Ventilation During RSV Hospitalization

    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.

    Measured: Through 30 days following the last injection of palivizumab

  6. Total Days of Mechanical Ventilation During RSV Hospitalization

    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.

    Measured: Through 30 days following the last injection of palivizumab

Timeline

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

  1. First posted3 Nov 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionApr 2010
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01006629
Sponsor's protocol ID
W10-664
Status last verified
Jun 2011
First submitted
2 Nov 2009
Last updated
19 Jul 2011

Publications

  • Turti TV, Baibarina EN, Degtiareva EA, Keshishyan ES, Lobzin YV, Namazova-capital VE, Cyrillicaranova LS, Prodeus AP, Gudkov KM, Kruglova AI, Schulz GA, Notario GF. A prospective, open-label, non-comparative study of palivizumab prophylaxis in children at high risk of serious respiratory syncytial virus disease in the Russian Federation. BMC Res Notes. 2012 Sep 4;5:484. doi: 10.1186/1756-0500-5-484.

    PubMed 22943074

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing palivizumab in people with Respiratory Syncytial Virus Infection and Premature Birth, run by Abbott at 19 sites in Russia.

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 6 inclusion and 15 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 19 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2011). 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?

Frequency of Adverse Events (time frame: Through 30 days following the last injection of palivizumab). The study lists 2 primary outcomes in all. 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 NCT01006629, which also lists 1 linked publication.

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 19 Jul 2011.

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