Motavizumab Administration for a Second Season for RSV ProphylaxisPhase 1/2NCT00113490

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524) After Dosing for a Second Season in Children

A Phase 1/2 study testing motavizumab (MEDI-524) and palivizumab 15 mg/kg in people with Motavizumab Administration for a Second Season for RSV Prophylaxis, run by MedImmune LLC at 6 sites in 2 countries.

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

The primary objective of this study was to determine the effect on immune reactivity to motavizumab (MEDI-524) of monthly intramuscular (IM) doses of motavizumab (MEDI-524) administered for a second season in children. Read more about this study

Who is it for?: Ages Up to 24 months
Conditions the study is for: Motavizumab Administration for a Second Season for RSV Prophylaxis
What is being tested?: motavizumab (MEDI-524) and palivizumab 15 mg/kg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 136 participants
Where: 6 sitesin 2 countries
Study dates: May 2005to Feb 2006
Phase: Phase 1/2
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

Previous participation in MI-CP104 and received at least 3 injections of MEDI-524 in MI-CP104
The child must be less than or equal to 24 months of age at time of entry into the study (child must be entered on or before their 24-month birthday)
The child must be able to complete the follow-up visits through 3-4 months after last dose (total length of participation of 6-8 months)
Written informed consent obtained from the patient's parent(s) or legal guardian

Who cannot join

Currently hospitalized
Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure [CPAP])
Evidence of infection with hepatitis A, B, or C virus
Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection
Suspected serious allergic or immune mediated events with prior receipt of MEDI-524
Acute illness or progressive clinical disorder

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Active infection, including acute respiratory syncytial virus (RSV) infection at the time of enrollment
Previous reaction to IGIV, blood products, or other foreign proteins
Have ever received palivizumab
Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV [RespiGam(R)], IVIG), or any investigational agents (except MEDI-524)
Currently participating in any investigational study

Trial locations and contacts

6 sites in 2 countries.

Country

City, postcode or hospital

6 sites in 2 countries

Chile4 sites

Hospital Clinico De La Pointificia Universidad
Santiago
Hospital Clinico de la Universidad de Chile
Santiago
Hospital Dr. Sotero Del Rio
Santiago
Hospital San Jose
Santiago

Other trials in Chile

Brazil2 sites

Pontificia Universidade Catolica Do Rio Grande
Porto Alegre, 90610-000
Hospital Das Clinicas Da Faculdade
Ribeirão Preto, 14049-900

Other trials in Brazil

About this study

Official title: A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), After Dosing for a Second Season in Children Who Previously Received MEDI-524 in Protocol MI-CP104

Read the detailed description

This was a Phase 1/2, randomized, double-blind study in which motavizumab (MEDI-524) or palivizumab was administered to children who previously participated in MI-CP104. Children who received at least 3 doses of motavizumab in MI-CP104 were eligible for enrollment. Subjects were randomized 1:1 to receive motavizumab or palivizumab at 15 mg/kg by IM injection every 30 days for a total of 4-5 injections during the 2004-05 RSV season subsequent to the season in which they were participants of MI-CP104. All subjects were evaluated prior to and 30 minutes after each injection of study drug with 2 follow-up evaluations, one at 30 days and the other at 90-120 days after the last dose.

Conditions: Motavizumab Administration for a Second Season for RSV Prophylaxis
Being tested: motavizumab (MEDI-524), palivizumab 15 mg/kg
Keywords: motavizumab, palivizumab, synagis, Rezield, MEDI-524

What participants receive

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

motavizumab (MEDI-524)Biological
Also called motavizumab, Rezield
Patients will receive 15 mg/kg MEDI-524 administered IM every 30 days for a total of 4-5 injections.
palivizumab 15 mg/kgBiological
Also called synagis
Patients will receive 15 mg/kg palivizumab administered IM every 30 days for a total of 4-5 injections.

Study groups in NCT00113490
Study group	Role	What they receive
motavizumab (MEDI-524) 15 mg/kg	Experimental	A single IM injection every 30 days beginning at Day 0 for a total of 4-5 injections determined by when in the RSV season a child was enrolled. Receives: Biological: motavizumab (MEDI-524)
palivizumab 15 mg/kg	Active comparator	A single IM injection every 30 days beginning at Day 0 for a total of 4-5 injections determined by when in the RSV season a child was enrolled. Receives: Biological: palivizumab 15 mg/kg

What is being measured

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

Number of Subjects Exhibiting Anti-motavizumab Antibodies
Serum for measurement of anti-motavizumab antibodies was collected prior to the first, second and, if applicable, fifth doses of study drug, and at the 2 follow-up visits 30 and 90-120 days post final dose.
Measured: Day 0 through 120 days post final dose

Secondary outcomes (4)

Number of Subjects Reporting Adverse Events (AEs)
Assessments of adverse events (including SAEs) were made by clinical investigators according to the protocol.
Measured: Day 0 through 30 days post final dose
Number of Subjects Reporting Serious Adverse Events (SAEs)
Assessments of SAEs were made by clinical investigators according to the protocol.
Measured: Day 0 through 30 days post final dose
Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations
Serum chemistry and hematology parameters were measured at baseline, on Days 25-30 and 120, 30 days post the final dose, and at premature discontinuation.
Measured: Day 0 through 30 days post final dose
Motavizumab Serum Concentrations at Each Data Collection Visit
Mean serum concentration.
Measured: Prior to dosing on Day 0, Day 30, Day 120, and at 30 and 90-120 days post final dose

Timeline

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

May 2005Feb 2006

First posted9 Jun 2005 (estimated)
Study startMay 2005
Primary completionFeb 2006
Study completionFeb 2006

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 Motavizumab Administration for a Second Season for RSV ProphylaxisStudies 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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 136 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00113490
Sponsor's protocol ID: MI-CP118
Status last verified: Apr 2013
First submitted: 8 Jun 2005
Last updated: 22 May 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Abarca K, Jung E, Fernandez P, Zhao L, Harris B, Connor EM, Losonsky GA; Motavizumab Study Group. Safety, tolerability, pharmacokinetics, and immunogenicity of motavizumab, a humanized, enhanced-potency monoclonal antibody for the prevention of respiratory syncytial virus infection in at-risk children. Pediatr Infect Dis J. 2009 Apr;28(4):267-72. doi: 10.1097/INF.0b013e31818ffd03.
PubMed 19258920

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), After Dosing for a Second Season in Children Who Previously Received MEDI-524 in Protocol MI-CP104
ClinicalTrials.gov ID: NCT00113490
Acronym / sponsor ID: MI-CP118
Conditions: Motavizumab Administration for a Second Season for RSV Prophylaxis
Keywords: motavizumab, palivizumab, synagis, Rezield, MEDI-524
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 136 participants (actual)
Lead sponsor: MedImmune LLCIndustry (pharma, biotech, devices)
Study start: May 2005
Primary completion: Feb 2006 (actual)
Study completion: Feb 2006 (actual)
First posted: 9 Jun 2005 (estimated)
Results: Posted 22 May 2013

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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
motavizumab (MEDI-524) 15 mg/kg	Experimental	Biological: motavizumab (MEDI-524)A single IM injection every 30 days beginning at Day 0 for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
palivizumab 15 mg/kg	Active comparator	Biological: palivizumab 15 mg/kgA single IM injection every 30 days beginning at Day 0 for a total of 4-5 injections determined by when in the RSV season a child was enrolled.

Who may qualify

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

Key inclusion criteria (4 listed)

Previous participation in MI-CP104 and received at least 3 injections of MEDI-524 in MI-CP104
The child must be less than or equal to 24 months of age at time of entry into the study (child must be entered on or before their 24-month birthday)
The child must be able to complete the follow-up visits through 3-4 months after last dose (total length of participation of 6-8 months)
Written informed consent obtained from the patient's parent(s) or legal guardian

Key exclusion criteria (11 listed)

Currently hospitalized
Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure [CPAP])
Evidence of infection with hepatitis A, B, or C virus
Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection
Suspected serious allergic or immune mediated events with prior receipt of MEDI-524

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
motavizumab (MEDI-524)Also: motavizumab, RezieldPatients will receive 15 mg/kg MEDI-524 administered IM every 30 days for a total of 4-5 injections.	Biological	motavizumab (MEDI-524) 15 mg/kg
palivizumab 15 mg/kgAlso: synagisPatients will receive 15 mg/kg palivizumab administered IM every 30 days for a total of 4-5 injections.	Biological	palivizumab 15 mg/kg

Primary outcome

Number of Subjects Exhibiting Anti-motavizumab Antibodies
Time frame: Day 0 through 120 days post final dose
Serum for measurement of anti-motavizumab antibodies was collected prior to the first, second and, if applicable, fifth doses of study drug, and at the 2 follow-up visits 30 and 90-120 days post final dose.

4 secondary outcomes

Number of Subjects Reporting Adverse Events (AEs)
Time frame: Day 0 through 30 days post final dose
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: Day 0 through 30 days post final dose
Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations
Time frame: Day 0 through 30 days post final dose
Motavizumab Serum Concentrations at Each Data Collection Visit
Time frame: Prior to dosing on Day 0, Day 30, Day 120, and at 30 and 90-120 days post final dose

Results and safety

Results posted to the registry on 22 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Motavizumab (MEDI-524) 15 mg/kg	66	64
Palivizumab 15 mg/kg	70	67

Primary outcome: Number of Subjects Exhibiting Anti-motavizumab Antibodies

Time frame: Day 0 through 120 days post final dose. Number. Unit: participants

Measure	Motavizumab (MEDI-524) 15 mg/kg n = 66	Palivizumab 15 mg/kg n = 70
Day 0	2	3
Day 25-30	0	3
Day 120	0	6
30 Days Post Final Dose	0	9
90-120 Days Post Final Dose	0	10
At any time	2	12

Population analysed: All subjects who received any study drug were included in all summaries of immunogenicity. Day 0 n=66 mota, n=70 pali; Day 25-30 n=65 mota, n=69 pali; Day 120 n=64 mota, n=67 pali; 30 days post final dose n=65 mota, n=67 pali; 90-120 days post final dose n=64 mota, n=67 pali; at any time n=66 mota, n=70 pali.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 0 through 30 days post final dose.. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Motavizumab (MEDI-524) 15 mg/kg	4 of 66 (6.1%)	56 of 66 (84.8%)	Not reported
Palivizumab 15 mg/kg	1 of 70 (1.4%)	62 of 70 (88.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19258920Abarca K, Jung E, Fernandez P, Zhao L, Harris B, Connor EM, Losonsky GA; Motavizumab Study Group. Safety, tolerability, pharmacokinetics, and immunogenicity of motavizumab, a humanized, enhanced-potency monoclonal antibody for the prevention of respiratory syncytial virus infection in at-risk children. Pediatr Infect Dis J. 2009 Apr;28(4):267-72. doi: 10.1097/INF.0b013e31818ffd03.

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.

M Pamela Griffin, M.D. study director

MedImmune LLC

6 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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 22 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Chile, Brazil. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 22 May 2013). 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 Exhibiting Anti-motavizumab Antibodies (time frame: Day 0 through 120 days post final dose). 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 NCT00113490, 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 22 May 2013.