CClinicalTrials.gg
Sign In
CompletedNCT00316264Updated Dec 11, 2012Results posted

Study of Motavizumab (MEDI-524) and Palivizumab Administered Sequentially in the Same Respiratory Syncytial Virus (RSV) Season

A Phase 2 interventional study of Motavizumab, palivizumab and Palivizumab, motavizumab in Respiratory Syncytial Virus Infections, Chronic Lung Disease and <= 24 Months of Age or and Premature With Gestational Age <=35 Weeks and <=6 Months of Age, sponsored by MedImmune LLC. Completed at 19 sites in 3 countries. Open to participants aged Up to 24 Months. Per ClinicalTrials.gov, last updated 2012-12-11.

Sponsored by MedImmune LLC · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
260
Allocation
Randomized
Ages
Up to 24 Months
Sex
All
01

Study 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 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.

02

Conditions studied

  • 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
03

In context

Respiratory Syncytial Virus Infections

293 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 45 are open to participants now.

This study's enrollment of 260 is above the median of 90 across 213 interventional studies indexed under Respiratory Syncytial Virus Infections.

Browse Respiratory Syncytial Virus Infections studies →

Lead sponsor

MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 24 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
260 participants (actual)

Study arms

  • Experimental
    Motavizumab followed by Palivizumab

    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)

    Biological: Motavizumab, palivizumab

  • Experimental
    Palivizumab followed by motavizumab

    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)

    Biological: Palivizumab, motavizumab

  • Experimental
    Motavizumab control

    5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)

    Biological: Motavizumab

Interventions

  • BiologicalMotavizumab, palivizumab

    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.

  • BiologicalPalivizumab, motavizumab

    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.

  • BiologicalMotavizumab

    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.

06

What researchers measure

Primary outcomes

  1. Number of Subjects Reporting Serious Adverse Events (SAEs)

    Time frame: Day 0 - Day 150

  2. Number of Subjects Reporting Adverse Events (AEs)

    Time frame: Day 0 - Day 150

  3. 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.

    Time frame: Day 0 - Day 150

Secondary outcomes

  1. The Serum Concentrations of Motavizumab at Day 0

    Time frame: Day 0

  2. The Trough Serum Concentrations of Motavizumab at Day 60

    Time frame: Day 60

  3. The Trough Serum Concentrations of Motavizumab at Day 150

    Time frame: Day 150

  4. The Trough Serum Concentrations of Motavizumab 120-150 Days Post Final Dose

    Time frame: 120-150 days post final dose

  5. The Serum Concentrations of Palivizumab at Day 0

    Time frame: Day 0

  6. The Trough Serum Concentrations of Palivizumab at Day 60

    Time frame: Day 60

  7. The Trough Serum Concentrations of Palivizumab at Day 150

    Time frame: Day 150

  8. The Trough Serum Concentrations of Palivizumab at 120-150 Days Post Final Dose

    Time frame: 120-150 days post final dose

  9. 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.

    Time frame: Day 0

  10. 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.

    Time frame: Day 60

  11. 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.

    Time frame: Day 150

  12. 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.

    Time frame: 120 - 150 days post final dose

  13. 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.

    Time frame: At any time

  14. 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.

    Time frame: Day 0

  15. 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.

    Time frame: Day 60

  16. 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.

    Time frame: Day 150

  17. 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.

    Time frame: 120 - 150 days post final pose

  18. 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.

    Time frame: At any time

07

Results

Posted Dec 11, 2012

Participant flow

It was anticipated that approximately 240 children (80 in each group) would be enrolled from the southern hemisphere during the upcoming RSV season (2006).

Participant flow — Overall Study
MilestoneMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
Started838493
Completed777787
Not completed676
Withdrew: Lost to follow-up010
Withdrew: Withdrawal of consent356
Withdrew: Death200
Withdrew: Other110

Outcome measures

PrimaryNumber of Subjects Reporting Serious Adverse Events (SAEs)
Time frame:
Day 0 - Day 150
Reported as:
Number · participants
Number of Subjects Reporting Serious Adverse Events (SAEs)
participantsMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
Number of Subjects Reporting Serious Adverse Events (SAEs)19711
PrimaryNumber of Subjects Reporting Adverse Events (AEs)
Time frame:
Day 0 - Day 150
Reported as:
Number · participants
Number of Subjects Reporting Adverse Events (AEs)
participantsMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
Number of Subjects Reporting Adverse Events (AEs)777583
PrimaryNumber 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.

Time frame:
Day 0 - Day 150
Reported as:
Number · participants
Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs.
participantsMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
Alanine aminotransferase increased115
Hepatic enzyme increased100
Liver function test abnormal001
Blood urea increased113
Aspartate aminotransferase increased232
SecondaryThe Serum Concentrations of Motavizumab at Day 0
Time frame:
Day 0
Reported as:
Mean · μg/mL
The Serum Concentrations of Motavizumab at Day 0
μg/mLMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
The Serum Concentrations of Motavizumab at Day 0NA ± NANA ± NANA ± NA
SecondaryThe Trough Serum Concentrations of Motavizumab at Day 60
Time frame:
Day 60
Reported as:
Mean · μg/mL
The Trough Serum Concentrations of Motavizumab at Day 60
μg/mLMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
The Trough Serum Concentrations of Motavizumab at Day 6074.74 ± 27.500.9417 ± 2.28778.02 ± 28.98
SecondaryThe Trough Serum Concentrations of Motavizumab at Day 150
Time frame:
Day 150
Reported as:
Mean · μg/mL
The Trough Serum Concentrations of Motavizumab at Day 150
μg/mLMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
The Trough Serum Concentrations of Motavizumab at Day 1508.801 ± 5.68293.05 ± 30.97105.8 ± 37.49
SecondaryThe Trough Serum Concentrations of Motavizumab 120-150 Days Post Final Dose
Time frame:
120-150 days post final dose
Reported as:
Mean · μg/mL
The Trough Serum Concentrations of Motavizumab 120-150 Days Post Final Dose
μg/mLMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
The Trough Serum Concentrations of Motavizumab 120-150 Days Post Final Dose0.5078 ± 1.0317.586 ± 5.15210.01 ± 6.341
SecondaryThe Serum Concentrations of Palivizumab at Day 0
Time frame:
Day 0
Reported as:
Mean · μg/mL
The Serum Concentrations of Palivizumab at Day 0
μg/mLMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
The Serum Concentrations of Palivizumab at Day 0NA ± NANA ± NANA ± NA
SecondaryThe Trough Serum Concentrations of Palivizumab at Day 60
Time frame:
Day 60
Reported as:
Mean · μg/mL
The Trough Serum Concentrations of Palivizumab at Day 60
μg/mLMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
The Trough Serum Concentrations of Palivizumab at Day 608.103 ± 6.90787.37 ± 17.418.795 ± 6.578
SecondaryThe Trough Serum Concentrations of Palivizumab at Day 150
Time frame:
Day 150
Reported as:
Mean · μg/mL
The Trough Serum Concentrations of Palivizumab at Day 150
μg/mLMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
The Trough Serum Concentrations of Palivizumab at Day 150107.4 ± 30.2122.89 ± 5.63112.99 ± 7.472
SecondaryThe Trough Serum Concentrations of Palivizumab at 120-150 Days Post Final Dose
Time frame:
120-150 days post final dose
Reported as:
Mean · μg/mL
The Trough Serum Concentrations of Palivizumab at 120-150 Days Post Final Dose
μg/mLMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
The Trough Serum Concentrations of Palivizumab at 120-150 Days Post Final Dose7.667 ± 7.719NA ± NANA ± NA
SecondaryThe 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.

Time frame:
Day 0
Reported as:
Number · participants with detected antibody
The Immunogenicity of Motavizumab at Day 0
participants with detected antibodyMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
The Immunogenicity of Motavizumab at Day 0010
SecondaryThe 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.

Time frame:
Day 60
Reported as:
Number · participants with detected antibody
The Immunogenicity of Motavizumab at Day 60
participants with detected antibodyMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
The Immunogenicity of Motavizumab at Day 60000
SecondaryThe 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.

Time frame:
Day 150
Reported as:
Number · participants with detected antibody
The Immunogenicity of Motavizumab at Day 150
participants with detected antibodyMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
The Immunogenicity of Motavizumab at Day 150110
SecondaryThe 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.

Time frame:
120 - 150 days post final dose
Reported as:
Number · participants with detected antibody
The Immunogenicity of Motavizumab at 120 to 150 Days Post Final Dose
participants with detected antibodyMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
The Immunogenicity of Motavizumab at 120 to 150 Days Post Final Dose310
SecondaryThe 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.

Time frame:
At any time
Reported as:
Number · participants with detected antibody
The Immunogenicity of Motavizumab at Any Time
participants with detected antibodyMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
The Immunogenicity of Motavizumab at Any Time420
SecondaryThe 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.

Time frame:
Day 0
Reported as:
Number · participants with detected antibody
The Immunogenicity of Palivizumab at Day 0
participants with detected antibodyMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
The Immunogenicity of Palivizumab at Day 0000
SecondaryThe 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.

Time frame:
Day 60
Reported as:
Number · participants with detected antibody
The Immunogenicity of Palivizumab at Day 60
participants with detected antibodyMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
The Immunogenicity of Palivizumab at Day 60111
SecondaryThe 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.

Time frame:
Day 150
Reported as:
Number · participants with detected antibody
The Immunogenicity of Palivizumab at Day 150
participants with detected antibodyMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
The Immunogenicity of Palivizumab at Day 150210
SecondaryThe 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.

Time frame:
120 - 150 days post final pose
Reported as:
Number · participants with detected antibody
The Immunogenicity of Palivizumab at 120 to 150 Days Post Final Dose
participants with detected antibodyMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
The Immunogenicity of Palivizumab at 120 to 150 Days Post Final Dose300
SecondaryThe 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.

Time frame:
At any time
Reported as:
Number · participants with detected antibody
The Immunogenicity of Palivizumab at Any Time
participants with detected antibodyMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
The Immunogenicity of Palivizumab at Any Time421

Adverse events

Collected over Day 0 - Day 150. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Motavizumab (MEDI-524) Followed by Palivizumab—19/83 (22.9%)75/83 (90.4%)
Palivizumab Followed by Motavizumab (MEDI-524)—7/83 (8.4%)74/83 (89.2%)
Motavizumab (MEDI-524) Control—11/93 (11.8%)83/93 (89.2%)
Most frequent serious events
Showing 10 of 27
Most frequent serious events
EventMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
BRONCHIOLITISInfections and infestations6/831/833/93
PNEUMONIAInfections and infestations3/830/831/93
INGUINAL HERNIAGastrointestinal disorders0/832/831/93
Visual disturbanceEye disorders1/830/830/93
GASTROOESOPHAGEAL REFLUX DISEASEGastrointestinal disorders1/830/830/93
BRONCHITISInfections and infestations1/830/830/93
BRONCHITIS VIRALInfections and infestations1/830/830/93
CROUP INFECTIOUSInfections and infestations1/830/830/93
GASTROENTERITISInfections and infestations1/830/830/93
LOWER RESPIRATORY TRACT INFECTIONInfections and infestations0/831/830/93
Most frequent other events
Showing 10 of 63
Most frequent other events
EventMotavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) Control
NASOPHARYNGITISInfections and infestations25/8326/8323/93
BRONCHITISInfections and infestations14/8320/8319/93
UPPER RESPIRATORY TRACT INFECTIONInfections and infestations17/8315/8318/93
WHEEZINGRespiratory, thoracic and mediastinal disorders15/838/8310/93
CONJUNCTIVITISEye disorders6/8311/8316/93
TEETHINGGastrointestinal disorders10/839/8316/93
RHINITISInfections and infestations10/8314/838/93
DIARRHOEAGastrointestinal disorders12/8313/8311/93
IRRITABILITYGeneral disorders10/8311/8311/93
DERMATITIS DIAPERSkin and subcutaneous tissue disorders5/8310/8310/93

Baseline characteristics

Age Continuous
Age Continuous(months)Motavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) ControlTotal
Mean3.68 ± 3.133.35 ± 2.253.92 ± 2.433.66 ± 2.62
Sex: Female, Male
Sex: Female, Male(Participants)Motavizumab (MEDI-524) Followed by PalivizumabPalivizumab Followed by Motavizumab (MEDI-524)Motavizumab (MEDI-524) ControlTotal
Female324145118
Male514348142
08

Study locations

19 sites
  • Department of Paediatrics and Child Health, The Canberra Hospital
    Garran, Australian Capital Territory 2605, Australia
  • Neonatalogy John Hunter Hospital
    New Lambton Heights, New South Wales 2305, Australia
  • Caboolture Clinical Research
    Caboolture, Queensland 4510, Australia
  • University of Queensland, Royal Children's Hospital
    Herston, Queensland 4029, Australia
  • Peninsula Clinical Research Centre
    Kippa-Ring, Queensland 4021, Australia
  • Women's and Children's Hospital
    North Adelaide, South Australia 5006, Australia
  • Respiratory Medicine Department, Royal Children's Hospital
    Parkville, Victoria 3052, Australia
  • Hospital Clinico de la Universidad de Chile
    Independencia, Santiago, Chile
  • Hospital San Jose
    Independencia, Santiago, Chile
  • Hospital Clinico de la Pontificia Universidad Catolica de Chile
    Santiago, Chile
  • Hospital Clinico San Borja Arriaran
    Santiago, Chile
  • Hospital Dr Felix Bulnes Cerda
    Santiago, Chile
  • Hospital Dr. Sotero del Rio
    Santiago, Chile
  • Hospital Padre Hurtado
    Santiago, Chile
  • Kidz First, Middlemore Hospital
    Otahuhu, Auckland, New Zealand
  • Christchurch Women's Hospital
    Christchurch, New Zealand
  • Paediatric Medicine, Dunedin Hospital
    Dunedin, New Zealand
  • Department of Paediatrics, Waikato Hospital
    Hamilton, New Zealand
  • Child Health, Palmerston North Hospital
    Palmerston North, New Zealand
09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00316264
Lead sponsor
MedImmune LLC
Responsible party
Sponsor
First posted
Apr 20, 2006
Start date
Apr 2006
Primary completion
Feb 2007
Completion
Feb 2007
Results posted
Dec 11, 2012
Last update
Dec 11, 2012

Study contacts

Pamela Griffin, M.D.
study director · MedImmune LLC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Respiratory Syncytial Virus Infections→

Other studies from this sponsor

MedImmune LLC

Start the discussion