Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524) After Dosing for a Second Season in Children (NCT NCT00113490)

Last Updated: 2013-05-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

136 participants

Primary outcome timeframe

Day 0 through 120 days post final dose

Results posted on

2013-05-22

Participant Flow

Children who received at least 3 doses of motavizumab in Study MI-CP104 during the 2004-2005 RSV season were eligible for enrollment in this study. It was anticipated that approximately 150 children would be enrolled.

Motavizumab or palivizumab was administered to children, using a 1:1 randomization, at 15 mg/kg of study drug by IM injection every 30 days, for a total of 4-5 doses (determined by when in the RSV season a child was enrolled) during the 2005-2006 RSV season.

Participant milestones

Participant milestones
Measure	Motavizumab (MEDI-524) 15 mg/kg A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.	Palivizumab 15 mg/kg A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
Overall Study STARTED	66	70
Overall Study COMPLETED	64	67
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Motavizumab (MEDI-524) 15 mg/kg A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.	Palivizumab 15 mg/kg A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
Overall Study Withdrawal by Subject	1	3
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Motavizumab (MEDI-524) 15 mg/kg n=66 Participants A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.	Palivizumab 15 mg/kg n=70 Participants A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.	Total n=136 Participants Total of all reporting groups
Age Continuous	13.25 Months STANDARD_DEVIATION 3.13 • n=5 Participants	13.59 Months STANDARD_DEVIATION 2.89 • n=7 Participants	13.43 Months STANDARD_DEVIATION 3.00 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	32 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	38 Participants n=7 Participants	81 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	61 participants n=5 Participants	62 participants n=7 Participants	123 participants n=5 Participants
Race/Ethnicity, Customized White/Non-Hispanic	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants
Race/Ethnicity, Customized Other	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 through 120 days post final dose

Population: 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.

Outcome measures

Outcome measures
Measure	Motavizumab (MEDI-524) 15 mg/kg n=66 Participants A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.	Palivizumab 15 mg/kg n=70 Participants A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
Number of Subjects Exhibiting Anti-motavizumab Antibodies Day 0	2 participants	3 participants
Number of Subjects Exhibiting Anti-motavizumab Antibodies Day 25-30	0 participants	3 participants
Number of Subjects Exhibiting Anti-motavizumab Antibodies Day 120	0 participants	6 participants
Number of Subjects Exhibiting Anti-motavizumab Antibodies 30 Days Post Final Dose	0 participants	9 participants
Number of Subjects Exhibiting Anti-motavizumab Antibodies 90-120 Days Post Final Dose	0 participants	10 participants
Number of Subjects Exhibiting Anti-motavizumab Antibodies At any time	2 participants	12 participants

SECONDARY outcome

Timeframe: Day 0 through 30 days post final dose

Population: All subjects who received any study drug were included in all summaries of safety.

Assessments of adverse events (including SAEs) were made by clinical investigators according to the protocol.

Outcome measures

Outcome measures
Measure	Motavizumab (MEDI-524) 15 mg/kg n=66 Participants A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.	Palivizumab 15 mg/kg n=70 Participants A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
Number of Subjects Reporting Adverse Events (AEs)	56 participants	62 participants

SECONDARY outcome

Timeframe: Day 0 through 30 days post final dose

Population: All subjects who received any study drug were included in all summaries of safety.

Assessments of SAEs were made by clinical investigators according to the protocol.

Outcome measures

Outcome measures
Measure	Motavizumab (MEDI-524) 15 mg/kg n=66 Participants A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.	Palivizumab 15 mg/kg n=70 Participants A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
Number of Subjects Reporting Serious Adverse Events (SAEs)	4 participants	1 participants

SECONDARY outcome

Timeframe: Day 0 through 30 days post final dose

Population: All subjects who received any study drug were included in all summaries of safety.

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.

Outcome measures

Outcome measures
Measure	Motavizumab (MEDI-524) 15 mg/kg n=66 Participants A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.	Palivizumab 15 mg/kg n=70 Participants A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations ALT Increased	1 participants	0 participants
Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations Blood Urea Nitrogen Increased	0 participants	4 participants
Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations Anemia	3 participants	3 participants
Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations Eosinophil Count Increased	0 participants	2 participants
Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations Neutropenia	0 participants	2 participants
Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations AST increased	0 participants	2 participants
Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations Hemoglobin Decreased	1 participants	0 participants
Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations Eosinophilia	3 participants	4 participants

SECONDARY outcome

Timeframe: Prior to dosing on Day 0, Day 30, Day 120, and at 30 and 90-120 days post final dose

Population: All subjects who received any study drug were included in all summaries. Day 0 n= 66; Day 25-30 n=65; Day 120 n=63; 30 days post final dose n=63; 90-120 days post final dose n=62

Mean serum concentration.

Outcome measures

Outcome measures
Measure	Motavizumab (MEDI-524) 15 mg/kg n=66 Participants A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.	Palivizumab 15 mg/kg A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
Motavizumab Serum Concentrations at Each Data Collection Visit Day 0	1.536 ug/mL Standard Deviation 6.192	—
Motavizumab Serum Concentrations at Each Data Collection Visit Day 25-30	54.59 ug/mL Standard Deviation 16.05	—
Motavizumab Serum Concentrations at Each Data Collection Visit Day 120	86.21 ug/mL Standard Deviation 23.79	—
Motavizumab Serum Concentrations at Each Data Collection Visit 30 Days Post Final Dose	76.03 ug/mL Standard Deviation 27.13	—
Motavizumab Serum Concentrations at Each Data Collection Visit 90-120 Days Post Final Dose	12.2 ug/mL Standard Deviation 6.260	—

Adverse Events

Motavizumab (MEDI-524) 15 mg/kg

Serious events: 4 serious events

Other events: 56 other events

Deaths: 0 deaths

Palivizumab 15 mg/kg

Serious events: 1 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Motavizumab (MEDI-524) 15 mg/kg n=66 participants at risk A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.	Palivizumab 15 mg/kg n=70 participants at risk A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
Infections and infestations BRONCHITIS	1.5% 1/66 • Number of events 1 • Day 0 through 30 days post final dose.	0.00% 0/70 • Day 0 through 30 days post final dose.
Immune system disorders HYPERSENSITIVITY	1.5% 1/66 • Number of events 1 • Day 0 through 30 days post final dose.	0.00% 0/70 • Day 0 through 30 days post final dose.
Injury, poisoning and procedural complications PNEUMONITIS CHEMICAL	1.5% 1/66 • Number of events 1 • Day 0 through 30 days post final dose.	0.00% 0/70 • Day 0 through 30 days post final dose.
Infections and infestations PYELONEPHRITIS	1.5% 1/66 • Number of events 1 • Day 0 through 30 days post final dose.	0.00% 0/70 • Day 0 through 30 days post final dose.
Infections and infestations RESPIRATORY SYNCYTIAL VIRUS INFECTION	1.5% 1/66 • Number of events 1 • Day 0 through 30 days post final dose.	0.00% 0/70 • Day 0 through 30 days post final dose.
Injury, poisoning and procedural complications THERMAL BURN	0.00% 0/66 • Day 0 through 30 days post final dose.	1.4% 1/70 • Number of events 1 • Day 0 through 30 days post final dose.

Other adverse events

Additional Information

M. Pamela Griffin, MD/ Clinical Development

MedImmune

Phone: 301-398-0000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.The PIs also agree for data to be presented first as a joint, multi-center publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	Motavizumab (MEDI-524) 15 mg/kg n=66 participants at risk A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.	Palivizumab 15 mg/kg n=70 participants at risk A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
Blood and lymphatic system disorders ANAEMIA	4.5% 3/66 • Number of events 3 • Day 0 through 30 days post final dose.	4.3% 3/70 • Number of events 3 • Day 0 through 30 days post final dose.
Investigations BLOOD UREA INCREASED	0.00% 0/66 • Day 0 through 30 days post final dose.	5.7% 4/70 • Number of events 4 • Day 0 through 30 days post final dose.
Infections and infestations BRONCHITIS	31.8% 21/66 • Number of events 33 • Day 0 through 30 days post final dose.	27.1% 19/70 • Number of events 38 • Day 0 through 30 days post final dose.
Infections and infestations CANDIDA NAPPY RASH	4.5% 3/66 • Number of events 3 • Day 0 through 30 days post final dose.	2.9% 2/70 • Number of events 2 • Day 0 through 30 days post final dose.
Eye disorders CONJUNCTIVITIS	6.1% 4/66 • Number of events 4 • Day 0 through 30 days post final dose.	5.7% 4/70 • Number of events 4 • Day 0 through 30 days post final dose.
Skin and subcutaneous tissue disorders DERMATITIS ATOPIC	1.5% 1/66 • Number of events 1 • Day 0 through 30 days post final dose.	4.3% 3/70 • Number of events 3 • Day 0 through 30 days post final dose.
Skin and subcutaneous tissue disorders DERMATITIS DIAPER	0.00% 0/66 • Day 0 through 30 days post final dose.	7.1% 5/70 • Number of events 5 • Day 0 through 30 days post final dose.
Gastrointestinal disorders DIARRHOEA	16.7% 11/66 • Number of events 12 • Day 0 through 30 days post final dose.	14.3% 10/70 • Number of events 13 • Day 0 through 30 days post final dose.
Blood and lymphatic system disorders EOSINOPHILIA	4.5% 3/66 • Number of events 3 • Day 0 through 30 days post final dose.	5.7% 4/70 • Number of events 4 • Day 0 through 30 days post final dose.
Immune system disorders IMMUNISATION REACTION	3.0% 2/66 • Number of events 2 • Day 0 through 30 days post final dose.	5.7% 4/70 • Number of events 4 • Day 0 through 30 days post final dose.
General disorders INJECTION SITE ERYTHEMA	15.2% 10/66 • Number of events 16 • Day 0 through 30 days post final dose.	11.4% 8/70 • Number of events 10 • Day 0 through 30 days post final dose.
Infections and infestations LARYNGITIS	4.5% 3/66 • Number of events 4 • Day 0 through 30 days post final dose.	5.7% 4/70 • Number of events 4 • Day 0 through 30 days post final dose.
Infections and infestations NASOPHARYNGITIS	43.9% 29/66 • Number of events 38 • Day 0 through 30 days post final dose.	41.4% 29/70 • Number of events 44 • Day 0 through 30 days post final dose.
Infections and infestations OTITIS MEDIA	1.5% 1/66 • Number of events 1 • Day 0 through 30 days post final dose.	4.3% 3/70 • Number of events 3 • Day 0 through 30 days post final dose.
Infections and infestations OTITIS MEDIA ACUTE	6.1% 4/66 • Number of events 5 • Day 0 through 30 days post final dose.	4.3% 3/70 • Number of events 3 • Day 0 through 30 days post final dose.
Infections and infestations PHARYNGITIS	9.1% 6/66 • Number of events 6 • Day 0 through 30 days post final dose.	11.4% 8/70 • Number of events 10 • Day 0 through 30 days post final dose.
Infections and infestations PNEUMONIA	3.0% 2/66 • Number of events 2 • Day 0 through 30 days post final dose.	4.3% 3/70 • Number of events 3 • Day 0 through 30 days post final dose.
Skin and subcutaneous tissue disorders PRURIGO	3.0% 2/66 • Number of events 2 • Day 0 through 30 days post final dose.	5.7% 4/70 • Number of events 4 • Day 0 through 30 days post final dose.
General disorders PYREXIA	3.0% 2/66 • Number of events 2 • Day 0 through 30 days post final dose.	5.7% 4/70 • Number of events 4 • Day 0 through 30 days post final dose.
Infections and infestations RHINITIS	9.1% 6/66 • Number of events 6 • Day 0 through 30 days post final dose.	5.7% 4/70 • Number of events 6 • Day 0 through 30 days post final dose.
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	4.5% 3/66 • Number of events 3 • Day 0 through 30 days post final dose.	0.00% 0/70 • Day 0 through 30 days post final dose.
Infections and infestations TONSILLITIS	6.1% 4/66 • Number of events 6 • Day 0 through 30 days post final dose.	7.1% 5/70 • Number of events 5 • Day 0 through 30 days post final dose.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	4.5% 3/66 • Number of events 3 • Day 0 through 30 days post final dose.	5.7% 4/70 • Number of events 5 • Day 0 through 30 days post final dose.
Infections and infestations VARICELLA	4.5% 3/66 • Number of events 3 • Day 0 through 30 days post final dose.	0.00% 0/70 • Day 0 through 30 days post final dose.
Respiratory, thoracic and mediastinal disorders WHEEZING	21.2% 14/66 • Number of events 19 • Day 0 through 30 days post final dose.	22.9% 16/70 • Number of events 24 • Day 0 through 30 days post final dose.