Respiratory Syncytial Virus InfectionsPhase 2NCT00316264
Study of Motavizumab (MEDI-524) and Palivizumab Administered Sequentially in the Same Respiratory Syncytial Virus (RSV) Season
A Phase 2 study testing Motavizumab, palivizumab, Palivizumab, motavizumab and Motavizumab in people with Respiratory Syncytial Virus Infections and Chronic Lung Disease and <= 24 Months of Age or, run by MedImmune LLC at 19 sites in 3 countries.
Trial summary
This is a Phase 2, randomized, double-blind study in which motavizumab (MEDI-524) and palivizumab were administered sequentially to high-risk children during the same respiratory syncytial virus (RSV) season. A control group was administered only motavizumab. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Respiratory Syncytial Virus Infections, Chronic Lung Disease and <= 24 Months of Age or, Premature With Gestational Age <=35 Weeks and <=6 Months of Age
- What is being tested?
- Motavizumab, palivizumab, Palivizumab, motavizumab and Motavizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 19 sitesin 3 countries
- Study dates
- Apr 2006to Feb 2007
- Phase
- Phase 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
- The child must have been born at less than or equal to 35 weeks gestation and be less than or equal to 6 months of age at the time of entry into the study (child must be entered on or before his/her 6-month birthday); or the child must be less than or equal to 24 months of age at the time of entry into the study (child must be entered on or before his/her 24-month birthday) and diagnosed with chronic lung disease (CLD) of prematurity with stable or decreasing doses of diuretics, steroids, or bronchodilators, or treatment with supplemental oxygen, within the previous 6 months.
- The child must be in general good health at the time of study entry.
- The child's parent(s)/legal guardian must provide written informed consent.
- The child must be able to complete the follow-up visits through 120-150 days from last injection of study drug.
- Parent(s)/legal guardian of patient must have available telephone access.
Who cannot join
- Hospitalized at the time of study entry (unless discharge is expected within 10 days after entry into the study)
- Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure [CPAP])
- Congenital heart disease (CHD) (children with medically or surgically corrected [closed] patent ductus arteriosus and no other CHD may be enrolled)
- Evidence of infection with hepatitis A, B, or C virus
- Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection (a child of a mother with known HIV infection must be proven to be uninfected at the time of enrollment)
- Suspected serious allergic or immune-mediated events with prior receipt of palivizumab
Show all 12Show fewer
- Acute illness or progressive clinical disorder
- Active infection, including acute RSV infection, at the time of enrollment
- Previous reaction to intravenous immunoglobulin (IGIV), blood products, or other foreign proteins
- Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV [RespiGam], IVIG, or palivizumab) or any investigational agents
- Previous participation in a clinical trial of motavizumab
- Currently participating in any investigational study
Trial locations and contacts
19 sites in 3 countries.
19 sites in 3 countries
Australia7 sites
Caboolture Clinical Research
Caboolture, Queensland, 4510
Department of Paediatrics and Child Health, The Canberra Hospital
Garran, Australian Capital Territory, 2605
University of Queensland, Royal Children's Hospital
Herston, Queensland, 4029
Peninsula Clinical Research Centre
Kippa-Ring, Queensland, 4021
Neonatalogy John Hunter Hospital
New Lambton Heights, New South Wales, 2305
Women's and Children's Hospital
North Adelaide, South Australia, 5006
Respiratory Medicine Department, Royal Children's Hospital
Parkville, Victoria, 3052
Chile7 sites
Hospital Clinico de la Universidad de Chile
Independencia, Santiago Metropolitan
Hospital San Jose
Independencia, Santiago Metropolitan
Hospital Clinico de la Pontificia Universidad Catolica de Chile
Santiago
Hospital Clinico San Borja Arriaran
Santiago
Hospital Dr Felix Bulnes Cerda
Santiago
Hospital Dr. Sotero del Rio
Santiago
Hospital Padre Hurtado
Santiago
New Zealand5 sites
Christchurch Women's Hospital
Christchurch
Paediatric Medicine, Dunedin Hospital
Dunedin
Department of Paediatrics, Waikato Hospital
Hamilton
Kidz First, Middlemore Hospital
Otahuhu, Auckland
Child Health, Palmerston North Hospital
Palmerston North
About this study
Official title: A Phase 2, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), and Palivizumab When Administered in the Same Season
This is a Phase 2, randomized, double-blind study in which motavizumab (MEDI-524) and palivizumab were administered sequentially to high-risk children during the same respiratory syncytial virus (RSV) season. A control group was administered only motavizumab.
Read the detailed description
This is a Phase 2, randomized, double-blind study in which motavizumab and palivizumab were administered sequentially to high-risk children during the same RSV season. It was anticipated that approximately 240 children (80 in each group) would be enrolled from the southern hemisphere during the upcoming RSV season (2006). Children were randomized into one of three regimens in a 1:1:1 ratio; the first group received 2 doses of motavizumab followed by 3 doses of palivizumab; the second group received 2 doses of palivizumab followed by 3 doses of motavizumab; and the third group received 5 doses of motavizumab. Motavizumab or palivizumab was administered at 15 mg/kg by IM injection every 30 days, for a total of 5 injections.
- Conditions
- Respiratory Syncytial Virus Infections, Chronic Lung Disease and <= 24 Months of Age or, Premature With Gestational Age <=35 Weeks and <=6 Months of Age
- Being tested
- Motavizumab, palivizumab, Palivizumab, motavizumab, Motavizumab
- Keywords
- Respiratory Syncytial Virus, Premature and under 6 mos. of age, Chronic Lung Disease over 6 mos. of age, palivizumab, motavizumab, RSV
- Medical subject headings
- Respiratory Syncytial Virus Infections, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motavizumab, palivizumabBiological
Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl.
Palivizumab, motavizumabBiological
Palivizumab was provided in sterile vials containing 100 mg of palivizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine, and 1.6 mM glycine.
MotavizumabBiological
Motavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl.
| Study group | Role | What they receive |
|---|---|---|
| Motavizumab followed by Palivizumab | Experimental | 2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) Receives: Biological: Motavizumab, palivizumab |
| Palivizumab followed by motavizumab | Experimental | 2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) Receives: Biological: Palivizumab, motavizumab |
| Motavizumab control | Experimental | 5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) Receives: Biological: Motavizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Serious Adverse Events (SAEs)
Measured: Day 0 - Day 150
Number of Subjects Reporting Adverse Events (AEs)
Measured: Day 0 - Day 150
Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs.
Serum chemistry samples were collected at Day 0, Day 60, and Day 150. Values representing changes in severity according to the AE grading table were recorded as AEs.
Measured: Day 0 - Day 150
Secondary outcomes (18)
The Serum Concentrations of Motavizumab at Day 0
Measured: Day 0
The Trough Serum Concentrations of Motavizumab at Day 60
Measured: Day 60
The Trough Serum Concentrations of Motavizumab at Day 150
Measured: Day 150
The Trough Serum Concentrations of Motavizumab 120-150 Days Post Final Dose
Measured: 120-150 days post final dose
The Serum Concentrations of Palivizumab at Day 0
Measured: Day 0
The Trough Serum Concentrations of Palivizumab at Day 60
Measured: Day 60
The Trough Serum Concentrations of Palivizumab at Day 150
Measured: Day 150
The Trough Serum Concentrations of Palivizumab at 120-150 Days Post Final Dose
Measured: 120-150 days post final dose
The Immunogenicity of Motavizumab at Day 0
Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Measured: Day 0
The Immunogenicity of Motavizumab at Day 60
Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Measured: Day 60
The Immunogenicity of Motavizumab at Day 150
Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Measured: Day 150
The Immunogenicity of Motavizumab at 120 to 150 Days Post Final Dose
Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Measured: 120 - 150 days post final dose
The Immunogenicity of Motavizumab at Any Time
Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Measured: At any time
The Immunogenicity of Palivizumab at Day 0
Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Measured: Day 0
The Immunogenicity of Palivizumab at Day 60
Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Measured: Day 60
The Immunogenicity of Palivizumab at Day 150
Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Measured: Day 150
The Immunogenicity of Palivizumab at 120 to 150 Days Post Final Dose
Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Measured: 120 - 150 days post final pose
The Immunogenicity of Palivizumab at Any Time
Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.
Measured: At any time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionFeb 2007
- Study completionFeb 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 Respiratory Syncytial Virus InfectionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pamela Griffin, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316264
- Sponsor's protocol ID
- MI-CP127
- Status last verified
- Nov 2012
- First submitted
- 18 Apr 2006
- Last updated
- 11 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Fernandez P, Trenholme A, Abarca K, Griffin MP, Hultquist M, Harris B, Losonsky GA; Motavizumab Study Group. A phase 2, randomized, double-blind safety and pharmacokinetic assessment of respiratory syncytial virus (RSV) prophylaxis with motavizumab and palivizumab administered in the same season. BMC Pediatr. 2010 Jun 3;10:38. doi: 10.1186/1471-2431-10-38.
PubMed 20525274
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), and Palivizumab When Administered in the Same Season
- ClinicalTrials.gov ID
- NCT00316264
- Acronym / sponsor ID
- MI-CP127
- Conditions
- Respiratory Syncytial Virus Infections, Chronic Lung Disease and <= 24 Months of Age or, Premature With Gestational Age <=35 Weeks and <=6 Months of Age
- Keywords
- Respiratory Syncytial Virus, Premature and under 6 mos. of age, Chronic Lung Disease over 6 mos. of age, palivizumab, motavizumab, RSV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 20 Apr 2006 (estimated)
- Results
- Posted 11 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, randomized, double-blind study in which motavizumab (MEDI-524) and palivizumab were administered sequentially to high-risk children during the same respiratory syncytial virus (RSV) season. A control group was administered only motavizumab.
Detailed description
This is a Phase 2, randomized, double-blind study in which motavizumab and palivizumab were administered sequentially to high-risk children during the same RSV season. It was anticipated that approximately 240 children (80 in each group) would be enrolled from the southern hemisphere during the upcoming RSV season (2006). Children were randomized into one of three regimens in a 1:1:1 ratio; the first group received 2 doses of motavizumab followed by 3 doses of palivizumab; the second group received 2 doses of palivizumab followed by 3 doses of motavizumab; and the third group received 5 doses of motavizumab. Motavizumab or palivizumab was administered at 15 mg/kg by IM injection every 30 days, for a total of 5 injections.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motavizumab followed by Palivizumab | Experimental | Biological: Motavizumab, palivizumab2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) |
| Palivizumab followed by motavizumab | Experimental | Biological: Palivizumab, motavizumab2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) |
| Motavizumab control | Experimental | Biological: Motavizumab5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The child must have been born at less than or equal to 35 weeks gestation and be less than or equal to 6 months of age at the time of entry into the study (child must be entered on or before his/her 6-month birthday); or the child must be less than or equal to 24 months of age at the time of entry into the study (child must be entered on or before his/her 24-month birthday) and diagnosed with chronic lung disease (CLD) of prematurity with stable or decreasing doses of diuretics, steroids, or bronchodilators, or treatment with supplemental oxygen, within the previous 6 months.
- The child must be in general good health at the time of study entry.
- The child's parent(s)/legal guardian must provide written informed consent.
- The child must be able to complete the follow-up visits through 120-150 days from last injection of study drug.
- Parent(s)/legal guardian of patient must have available telephone access.
Key exclusion criteria (12 listed)
- Hospitalized at the time of study entry (unless discharge is expected within 10 days after entry into the study)
- Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure [CPAP])
- Congenital heart disease (CHD) (children with medically or surgically corrected [closed] patent ductus arteriosus and no other CHD may be enrolled)
- Evidence of infection with hepatitis A, B, or C virus
- Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection (a child of a mother with known HIV infection must be proven to be uninfected at the time of enrollment)
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, palivizumabMotavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl. | Biological | Motavizumab followed by Palivizumab |
| Palivizumab, motavizumabPalivizumab was provided in sterile vials containing 100 mg of palivizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine, and 1.6 mM glycine. | Biological | Palivizumab followed by motavizumab |
| MotavizumabMotavizumab was provided in sterile vials containing 100 mg of motavizumab in 1 mL of a sterile preservative-free liquid product at pH 6.0, formulated with 25 mM histidine-HCl. | Biological | Motavizumab control |
Primary outcome
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: Day 0 - Day 150
Number of Subjects Reporting Adverse Events (AEs)
Time frame: Day 0 - Day 150
Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs.
Time frame: Day 0 - Day 150
Serum chemistry samples were collected at Day 0, Day 60, and Day 150. Values representing changes in severity according to the AE grading table were recorded as AEs.
18 secondary outcomes
The Serum Concentrations of Motavizumab at Day 0
Time frame: Day 0
The Trough Serum Concentrations of Motavizumab at Day 60
Time frame: Day 60
The Trough Serum Concentrations of Motavizumab at Day 150
Time frame: Day 150
The Trough Serum Concentrations of Motavizumab 120-150 Days Post Final Dose
Time frame: 120-150 days post final dose
The Serum Concentrations of Palivizumab at Day 0
Time frame: Day 0
The Trough Serum Concentrations of Palivizumab at Day 60
Time frame: Day 60
The Trough Serum Concentrations of Palivizumab at Day 150
Time frame: Day 150
The Trough Serum Concentrations of Palivizumab at 120-150 Days Post Final Dose
Time frame: 120-150 days post final dose
The Immunogenicity of Motavizumab at Day 0
Time frame: Day 0
The Immunogenicity of Motavizumab at Day 60
Time frame: Day 60
The Immunogenicity of Motavizumab at Day 150
Time frame: Day 150
The Immunogenicity of Motavizumab at 120 to 150 Days Post Final Dose
Time frame: 120 - 150 days post final dose
The Immunogenicity of Motavizumab at Any Time
Time frame: At any time
The Immunogenicity of Palivizumab at Day 0
Time frame: Day 0
The Immunogenicity of Palivizumab at Day 60
Time frame: Day 60
The Immunogenicity of Palivizumab at Day 150
Time frame: Day 150
The Immunogenicity of Palivizumab at 120 to 150 Days Post Final Dose
Time frame: 120 - 150 days post final pose
The Immunogenicity of Palivizumab at Any Time
Time frame: At any time
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20525274Fernandez P, Trenholme A, Abarca K, Griffin MP, Hultquist M, Harris B, Losonsky GA; Motavizumab Study Group. A phase 2, randomized, double-blind safety and pharmacokinetic assessment of respiratory syncytial virus (RSV) prophylaxis with motavizumab and palivizumab administered in the same season. BMC Pediatr. 2010 Jun 3;10:38. doi: 10.1186/1471-2431-10-38.
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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.
Pamela Griffin, M.D. study director
MedImmune LLC
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Motavizumab, palivizumab, Palivizumab, motavizumab and Motavizumab in people with Respiratory Syncytial Virus Infections and Chronic Lung Disease and <= 24 Months of Age or, run by MedImmune LLC at 19 sites in 3 countries.
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 12 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 11 Dec 2012. 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 Australia, Chile, New Zealand. 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?
Yes. Results are posted in the registry (first posted 11 Dec 2012). 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 Reporting Serious Adverse Events (SAEs) (time frame: Day 0 - Day 150). The study lists 3 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 NCT00316264, 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 11 Dec 2012.