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

NCT00316264 | Completed Phase 2 Results DMC

• 1 other identifier: MI-CP127
• Study Type: interventional
• Target: 260
• Locations: 3 countries
• Sites: 19

Brief 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.

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

Outcome Measures

Primary Outcomes (3)

• Number of Subjects Reporting Serious Adverse Events (SAEs)

  Day 0 - Day 150

• Number of Subjects Reporting Adverse Events (AEs)

  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.

  Day 0 - Day 150

Secondary Outcomes (18)

• The Serum Concentrations of Motavizumab at Day 0

  Day 0

• The Trough Serum Concentrations of Motavizumab at Day 60

  Day 60

• The Trough Serum Concentrations of Motavizumab at Day 150

  Day 150

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

  120-150 days post final dose

• The Serum Concentrations of Palivizumab at Day 0

  Day 0

Study Arms (3)

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)

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)

Biological: Palivizumab, motavizumab

Motavizumab control

EXPERIMENTAL

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

Biological: Motavizumab

Interventions

Motavizumab, palivizumab BIOLOGICAL

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.

Motavizumab followed by Palivizumab

Palivizumab, motavizumab BIOLOGICAL

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.

Palivizumab followed by motavizumab

Motavizumab BIOLOGICAL

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.

Motavizumab control

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (19)

Department of Paediatrics and Child Health, The Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

Location

Neonatalogy John Hunter Hospital

New Lambton Heights, New South Wales, 2305, Australia

Location

Caboolture Clinical Research

Caboolture, Queensland, 4510, Australia

Location

University of Queensland, Royal Children's Hospital

Herston, Queensland, 4029, Australia

Location

Peninsula Clinical Research Centre

Kippa-Ring, Queensland, 4021, Australia

Location

Women's and Children's Hospital

North Adelaide, South Australia, 5006, Australia

Location

Respiratory Medicine Department, Royal Children's Hospital

Parkville, Victoria, 3052, Australia

Location

Hospital Clinico de la Universidad de Chile

Independencia, Santiago Metropolitan, Chile

Location

Hospital San Jose

Independencia, Santiago Metropolitan, Chile

Location

Hospital Clinico de la Pontificia Universidad Catolica de Chile

Santiago, Chile

Location

Hospital Clinico San Borja Arriaran

Santiago, Chile

Location

Hospital Dr Felix Bulnes Cerda

Santiago, Chile

Location

Hospital Dr. Sotero del Rio

Santiago, Chile

Location

Hospital Padre Hurtado

Santiago, Chile

Location

Kidz First, Middlemore Hospital

Otahuhu, Auckland, New Zealand

Location

Christchurch Women's Hospital

Christchurch, New Zealand

Location

Paediatric Medicine, Dunedin Hospital

Dunedin, New Zealand

Location

Department of Paediatrics, Waikato Hospital

Hamilton, New Zealand

Location

Child Health, Palmerston North Hospital

Palmerston North, New Zealand

Location

Related Publications (1)

• 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.

  PMID: 20525274 RESULT

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections; Premature Birth

Interventions

motavizumab; Palivizumab

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Pamela Griffin
• Organization: MedImmune

clinicaltrialenquiries@medimmune.com

301 398 0000

Study Officials

• Pamela Griffin, M.D.

  MedImmune LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2006
• First Posted: April 20, 2006
• Study Start: April 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: December 11, 2012
• Results First Posted: December 11, 2012

Record last verified: 2012-11

Locations

AU (7); CL (7); NZ (5)