Chronic Lung DiseasePhase 4NCT00233064

Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis)

A Phase 4 study testing Lyophilized Palivizumab and Liquid Palivizumab in people with Chronic Lung Disease, run by MedImmune LLC at 54 sites in United States.

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

Who is it for?: Ages Up to 24 months
Conditions the study is for: Chronic Lung Disease
What is being tested?: Lyophilized Palivizumab and Liquid Palivizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 417 participants
Where: 54 sitesUnited States
Study dates: Oct 2005to Nov 2007
Phase: Phase 4
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

Who may be able to join

Medically stable child with chronic lung disease of prematurity who is ≤24 months of age at randomization OR child with premature birth (gestational age ≤35 weeks or less) and who is 6 months of age or younger at randomization
Written informed consent obtained from the patient's parent(s) or legal guardian(s)
The child must be able to complete the follow-up visit 4-6 months after the last dose of study drug

Who cannot join

Hospitalization at the time of randomization (unless discharge is anticipated within 3 weeks)
Be receiving mechanical ventilation at the time of study entry (including CPAP)
Congenital heart disease (children with uncomplicated CHD [e.g., PDA, small septal defect] and children with complicated CHD who are currently anatomically and hemodynamically normal can be enrolled).
Mother with HIV infection (unless the child has been proven to be not infected)
Life expectancy <6 months
Known allergy to Ig products

Show all 11Show fewer

Acute respiratory or other acute infection or illness
Previous reaction to IGIV, blood products, or other foreign proteins
Receipt of lyophilized palivizumab, RSV-IG IV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, Hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization
Any previous receipt of MEDI-524
Participation in other investigational drug product studies

Trial locations and contacts

54 sites in 1 country.

City, postcode or hospital

54 sites in 1 country

United States54 sites

Physicians to Children and Adolescents
Bardstown, Kentucky, 40004
Tri-State Pediatrics
Beaver Falls, Pennsylvania, 15010
Birmingham Pediatric Associates
Birmingham, Alabama, 35235
Medcenter One/Q&R Clinic
Bismarck, North Dakota, 58501
Boston University Medical Center
Boston, Massachusetts, 02118
Maimonides Pediatric Pulmonology
Brooklyn, New York, 11230
WVU Department of Pediatrics
Charleston, West Virginia, 25202
Dr. Shelly David Senders, M.D., Inc.
Cleveland, Ohio, 44118
The Allergy Center at Brookstone
Columbus, Georgia, 31904
Sadler Clinic
Conroe, Texas, 77304
Pediatric Allergy/Immunology Associates, PA
Dallas, Texas, 75230
Pediatric Association of Fall River
Fall River, Massachusetts, 02724
Dakota Clinic, Ltd. / Innvois Health
Fargo, North Dakota, 58103
Family Medical Center
Foothill Ranch, California, 92610
Edinger Medical Group
Fountain Valley, California, 92708
Greenville Medical Center
Greenville, Pennsylvania, 16125
Clinical Research Consultants
Hoover, Alabama, 35216
MedPro Research
Houston, Texas, 77004
Pediatric Associates
Houston, Texas, 77087
Jackson Clinic
Jackson, Tennessee, 38305
Holston Medical Group; Pediatrics at Meadowview Lane
Kingsport, Tennessee, 37660
Holston Medical Group; Pediatrics at Stone Plaza
Kingsport, Tennessee, 37660
CCP - Armstrong Pediatrics
Kittanning, Pennsylvania, 16201
Pediatric Alliance of Latrobe
Latrobe, Pennsylvania, 15650
North Carolina Children's & Adult's Clinical Research Foundation/Purcell Clinic
Laurinburg, North Carolina, 28352
Wee Care Pediatrics
Layton, Utah, 84041
All for Kids Pediatric Clinic
Little Rock, Arkansas, 72211
Michigan Institute of Medicine
Livonia, Michigan, 41852
Northeast Cincinnati Pediatric Associates, Inc
Mason, Ohio, 45040
Trinity Medical Group-Health Center Medical Arts
Minot, North Dakota, 58701
Monroe Clinic
Monroe, Wisconsin, 53566
Norwich Pediatric Group, P.C.
Norwich, Connecticut, 06360
Bear Care Pediatrics
Ogden, Utah, 84405
Santiago Reyes, M.D.
Oklahoma City, Oklahoma, 73112
Meridian Clinical Research
Omaha, Nebraska, 68134
Peak Medical Research LLC
Owensboro, Kentucky, 42303
St. Joseph's Childrens Hospital
Paterson, New Jersey, 07503
Temple Univ. Children's Medical Center
Philadelphia, Pennsylvania, 19140
Pediatric Alliance, Southwestern
Pittsburgh, Pennsylvania, 15217
South Hills Pediatrics
Pittsburgh, Pennsylvania, 15227
Pediatric Alliance, Southwestern
Pittsburgh, Pennsylvania, 15236
Primary Physician's Research, Inc.
Pittsburgh, Pennsylvania, 15241
Utah Valley Pediatrics
Provo, Utah, 84604
Capitol Pediatric And Adolescent Center
Raleigh, North Carolina, 27609
Quality Assurance Research Center
San Antonio, Texas, 78205
Families First Pediatrics
South Jordan, Utah, 84095
North Carolina Children's and Adult's Clinical Research Foundation
Sylva, North Carolina, 28779
The University of Alabama School of Medicine
Tuscaloosa, Alabama, 35487
Laurel Pediatrics
Uniontown, Pennsylvania, 15401
Advanced Pediatrics
Vienna, Virginia, 22180
Brown Clinic P.L.L.P./Northridge Clinic
Watertown, South Dakota, 57201
Doctors Medical Group
West Covina, California, 91790
Convenience Care
West Covina, California, 91791
Woburn Pediatric Associates
Woburn, Massachusetts, 01801

Other trials in United States

About this study

Official title: A Phase IV, Randomized, Double-Blind Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis) in Children at High Risk for the Development of Serious RSV Disease

The purpose of this study is to measure the rate of anti-palivizumab antibodies (also referred to as immune reactivity or immunogenicity) in subjects receiving either the liquid or lyophilized formulation of palivizumab. This study will compare the number and percentage of subjects with anti-palivizumab antibodies receiving either the liquid or lyophilized formulation of palivizumab.

Read the detailed description

The approved liquid formulation of palivizumab was developed to simplify preparation of the drug before injection. Both formulations of palivizumab have been shown to be bioequivalent in children 6 months of age or younger with a history of chronic lung disease. In previous studies of liquid palivizumab, immunogenicity was evaluated up to 2 months after dosing in adults, and 1 month after dosing in children. In this study, MI-CP116, immunogenicity will be evaluated between 4 and 6 months after the last dose of study drug, in order to provide data at a time point significantly distant from dosing when drug interference is minimal.

Conditions: Chronic Lung Disease
Being tested: Lyophilized Palivizumab, Liquid Palivizumab

What participants receive

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

Lyophilized PalivizumabBiological
Also called Synagis
Patients will receive 15 mg/kg of lyophilized palivizumab administered intramuscularly every 30 days for a total of 5 injections.
Liquid PalivizumabBiological
Also called Synagis
Patients will receive 15 mg/kg of liquid palivizumab administered intramuscularly every 30 days for a total of 5 injections.

Study groups in NCT00233064
Study group	Role	What they receive
1	Active comparator	Liquid Palivizumab Receives: Biological: Liquid Palivizumab
2	Active comparator	Lyophilized Palivizumab Receives: Biological: Lyophilized Palivizumab

What is being measured

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

Number and Percentage of Participants With Immune Reactivity
Presence of anti-palivizumab antibodies
Measured: Day 240-300 follow up

Timeline

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

Oct 2005Nov 2007

First posted5 Oct 2005 (estimated)
Study startOct 2005
Primary completionOct 2007
Study completionNov 2007

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Lung DiseaseStudies 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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 417 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00233064
Sponsor's protocol ID: MI-CP116
Status last verified: Jan 2010
First submitted: 3 Oct 2005
Last updated: 27 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Makari D, Jensen KM, Harris B, Jafri HS. Randomized, Double-Blind Study of the Safety of the Liquid Versus Lyophilized Formulation of Palivizumab in Premature Infants and Children with Chronic Lung Disease of Prematurity. Infect Dis Ther. 2014 Dec;3(2):339-47. doi: 10.1007/s40121-014-0033-y. Epub 2014 Aug 26.
PubMed 25156956

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?

See locations

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All Chronic Lung Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV, Randomized, Double-Blind Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis) in Children at High Risk for the Development of Serious RSV Disease
ClinicalTrials.gov ID: NCT00233064
Acronym / sponsor ID: MI-CP116
Conditions: Chronic Lung Disease
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 417 participants (actual)
Lead sponsor: MedImmune LLCIndustry (pharma, biotech, devices)
Study start: Oct 2005
Primary completion: Oct 2007 (actual)
Study completion: Nov 2007 (actual)
First posted: 5 Oct 2005 (estimated)
Results: Posted 28 Oct 2008

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Biological: Liquid PalivizumabLiquid Palivizumab
2	Active comparator	Biological: Lyophilized PalivizumabLyophilized Palivizumab

Who may qualify

Ages: Up to 24 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Medically stable child with chronic lung disease of prematurity who is ≤24 months of age at randomization OR child with premature birth (gestational age ≤35 weeks or less) and who is 6 months of age or younger at randomization
Written informed consent obtained from the patient's parent(s) or legal guardian(s)
The child must be able to complete the follow-up visit 4-6 months after the last dose of study drug

Key exclusion criteria (11 listed)

Hospitalization at the time of randomization (unless discharge is anticipated within 3 weeks)
Be receiving mechanical ventilation at the time of study entry (including CPAP)
Congenital heart disease (children with uncomplicated CHD [e.g., PDA, small septal defect] and children with complicated CHD who are currently anatomically and hemodynamically normal can be enrolled).
Mother with HIV infection (unless the child has been proven to be not infected)
Life expectancy <6 months

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lyophilized PalivizumabAlso: SynagisPatients will receive 15 mg/kg of lyophilized palivizumab administered intramuscularly every 30 days for a total of 5 injections.	Biological	2
Liquid PalivizumabAlso: SynagisPatients will receive 15 mg/kg of liquid palivizumab administered intramuscularly every 30 days for a total of 5 injections.	Biological	1

Primary outcome

Number and Percentage of Participants With Immune Reactivity
Time frame: Day 240-300 follow up
Presence of anti-palivizumab antibodies

Results and safety

Results posted to the registry on 28 Oct 2008, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Liquid Palivizumab	211	197
Lyophilized Palivizumab	202	190

Primary outcome: Number and Percentage of Participants With Immune Reactivity

Time frame: Day 240-300 follow up. Number. Unit: Participants

Measure	Liquid Palivizumab n = 191	Lyophilized Palivizumab n = 188	Combined Liquid/Lyophilized Palivizumab n = 379
Number	0	1	1
Percentage	0.0	0.5	0.3

Liquid Palivizumab: Overall percentage of immune reactivity: 0.0 (95% CI 0.0 to 1.9)
Lyophilized Palivizumab: Overall percentage of immune reactivity: 0.5 (95% CI 0.0 to 2.9)
Combined Liquid/Lyophilized Palivizumab: Overall percentage of immune reactivity: 0.3 (95% CI 0.0 to 1.5)

Population analysed: Participants who received at least 2 doses of study drug and had at least 1 blood sample collected (at baseline or Study Day 240-300) were included in the analysis. This included 206 subjects in Arm 1 and 200 subjects in Arm 2. Of these subjects, 191 (Arm 1) and 188 (Arm 2) had adequate blood samples for analysis. This analysis was per protocol.

Adverse events

Time frame: Serious adverse events were collected from the time of the first study drug administration through Study Day 150. Adverse events were not collected in this study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liquid Palivizumab	18 of 211 (8.5%)	0 of 211 (0%)	Not reported
Lyophilized Palivizumab	12 of 202 (5.9%)	0 of 202 (0%)	Not reported

Limitations and caveats (from the sponsor): Only serious adverse events were collected as part of the safety evaluation. One death (asphyxia) occurred in the Lyophilized Palivizumab group; this event was judged not related to study drug.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25156956Makari D, Jensen KM, Harris B, Jafri HS. Randomized, Double-Blind Study of the Safety of the Liquid Versus Lyophilized Formulation of Palivizumab in Premature Infants and Children with Chronic Lung Disease of Prematurity. Infect Dis Ther. 2014 Dec;3(2):339-47. doi: 10.1007/s40121-014-0033-y. Epub 2014 Aug 26.

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Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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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.

Genny Losonsky, MD study director

MedImmune LLC

54 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lyophilized Palivizumab and Liquid Palivizumab in people with Chronic Lung Disease, run by MedImmune LLC at 54 sites in United States.

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 3 inclusion and 11 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 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States. 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 28 Oct 2008). 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 and Percentage of Participants With Immune Reactivity (time frame: Day 240-300 follow up). 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 NCT00233064, 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 27 Jun 2018.