-Unhealthy Children With a History of PrematurityPhase 2NCT00240929
A Phase II Randomized, Double-Blind, Two-Period Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palizvizumab (MEDI-493, Synagis)
A Phase 2 study testing MEDI-493 in people with -Unhealthy Children With a History of Prematurity, run by MedImmune LLC at 1 site in United States.
Trial summary
A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence A or B. Read more about this study
- Who is it for?
- Ages 5 to 6 months
- Conditions the study is for
- -Unhealthy Children With a History of Prematurity
- What is being tested?
- MEDI-493
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Apr 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 5 to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child must have been born at greater than or equal to 35 weeks gestation and be greater than or equal to 6 months of age at the time of randomization (child must be randomized on or before their 6-month birthday)
- The child's parent or legal guardian must provide written informed consent; and
- The child must be able to complete the follow-up visits on Study Days 30 and 60 within the protocol specified windows (±2 days)
- Parent/legal guardian of patient has available telephone access.
Who cannot join
- Be hospitalized;
- Birth hospitalization > 6 weeks duration;
- Be receiving mechanical ventilation at the time of study entry (including CPAP);
- Bronchopulmonary dysplasia (BPD), defined as history of prematurity and associated chronic lung disease with oxygen requirement for >28 days;
- Congenital heart disease (CHD). (Children with medically or surgically corrected [closed] patent ductus arteriosus and no other CHD may be enrolled.)
- Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency;
Show all 20Show fewer
- Any of the following laboratory findings in blood obtained within 7 days prior to study entry:
- BUN or creatinine >1.5´ the upper limit of normal for age
- AST (SGOT) or ALT (SGPT) >1.5´ the upper limit of normal for age
- hemoglobin <9.0 gm/dL
- white blood cell count <4,000 cells/mm3
- platelet count <110,000 cells/mm3
- Acute illness or progressive clinical disorder;
- History of recent difficult venous access;
- Active infection, including acute RSV infection;
- Previous reaction to IGIV, blood products, or other foreign proteins;
- Received within the past 120 days or currently receiving IGIV, other immunoglobulin products, or any investigational agents;
- Have ever received palivizumab;
- Currently participating in any investigational study; or
- Previously participated in any investigational study of RSV vaccines or monoclonal antibodies.
Trial locations and contacts
1 site in 1 country.
United States1 site
Packard Children's Hospital at Stanford
Palo Alto, California, 94304
About this study
Official title: A Phase II Randomized, Double-Blind, Two-Period Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palizvizumab (MEDI-493, Synagis), A Humanized Respiratory Syncytial Virus Monoclonal Antibody, in Children With a History of Prematurity
A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence A or B.
Read the detailed description
Phase II, Double-blind, two-period, cross-over study to be conducted at 20 sites the U.S. A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence: Sequence A (single dose of the liquid formulation on Study Day 0 and a single dose of the lyophilized formulation on Study Day 30) or Sequence B (single dose of the lyophized forumation on Study Day 0 and single dose of the liquid formulation on Study Day 30). Children will be followed for adverse events through 30 days after each injection of study drug and will have blood collected for determination of palivizumab concentrations in serum.
- Being tested
- MEDI-493
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-493Drug
Also called Synagis
Active Comparator
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events through 30 days after each injection of study drug and will have blood collected for determination of palivizumab concentrations in serum.
Measured: Day 30
Secondary outcomes (1)
Adverse events and serious adverse events for 30 days after each injection of study drug.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startSep 2002
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for -Unhealthy Children With a History of PrematurityStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Genevieve Losonsky, M.D., Study director, "Unaffliliated"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240929
- Sponsor's protocol ID
- MI-CP097
- Status last verified
- Nov 2010
- First submitted
- 14 Oct 2005
- Last updated
- 15 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-Blind, Two-Period Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palizvizumab (MEDI-493, Synagis), A Humanized Respiratory Syncytial Virus Monoclonal Antibody, in Children With a History of Prematurity
- ClinicalTrials.gov ID
- NCT00240929
- Acronym / sponsor ID
- MI-CP097
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Study completion
- Apr 2003 (actual)
- First posted
- 18 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence A or B.
Detailed description
Phase II, Double-blind, two-period, cross-over study to be conducted at 20 sites the U.S. A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence: Sequence A (single dose of the liquid formulation on Study Day 0 and a single dose of the lyophilized formulation on Study Day 30) or Sequence B (single dose of the lyophized forumation on Study Day 0 and single dose of the liquid formulation on Study Day 30). Children will be followed for adverse events through 30 days after each injection of study drug and will have blood collected for determination of palivizumab concentrations in serum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 5 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The child must have been born at greater than or equal to 35 weeks gestation and be greater than or equal to 6 months of age at the time of randomization (child must be randomized on or before their 6-month birthday)
- The child's parent or legal guardian must provide written informed consent; and
- The child must be able to complete the follow-up visits on Study Days 30 and 60 within the protocol specified windows (±2 days)
- Parent/legal guardian of patient has available telephone access.
Key exclusion criteria (20 listed)
- Be hospitalized;
- Birth hospitalization > 6 weeks duration;
- Be receiving mechanical ventilation at the time of study entry (including CPAP);
- Bronchopulmonary dysplasia (BPD), defined as history of prematurity and associated chronic lung disease with oxygen requirement for >28 days;
- Congenital heart disease (CHD). (Children with medically or surgically corrected [closed] patent ductus arteriosus and no other CHD may be enrolled.)
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 |
|---|---|---|
| MEDI-493Also: SynagisActive Comparator | Drug | – |
Primary outcome
adverse events through 30 days after each injection of study drug and will have blood collected for determination of palivizumab concentrations in serum.
Time frame: Day 30
1 secondary outcome
Adverse events and serious adverse events for 30 days after each injection of study drug.
Time frame: Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2010.
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.
Genevieve Losonsky, M.D. study director
"Unaffliliated"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEDI-493 in people with -Unhealthy Children With a History of Prematurity, run by MedImmune LLC at 1 site 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 4 inclusion and 20 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 15 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
adverse events through 30 days after each injection of study drug and will have blood collected for determination of palivizumab concentrations in serum. (time frame: Day 30). 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 15 Nov 2010; AzTrials last refreshed its copy on 30 Oct 2026.