A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety of MEDI-559 in Healthy 1 to <24 Month-Old Children - MEDI-559

Study identifier:MI-CP147

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1/2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, and Viral Shedding of MEDI-559, a Live Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus in Healthy 1 to <24 Month-Old Children

Medical condition

Healthy

Phase

Phase 1/2

Healthy volunteers

Yes

Study drug

Sex

All

Actual Enrollment

116

Study type

Interventional

Age

1 Months - 23 Months

Date

Study Start Date: 01 Oct 2008

Primary Completion Date: 01 Dec 2011

Study Completion Date: 01 Aug 2012

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2012 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Male or female whose age on the day of randomization falls within one of the two age cohorts: Cohort 1: 5 to <24 months (reached their 5th month birthday but not yet reached their 2nd year birthday); Cohort 2: 1 to < 3 months (>28 days of age and not yet reached their 3rd month birthday)
- Cohort 1 only: Subject is seronegative to RSV at screening
- Subject was the product of normal full term pregnancy (defined as 36-42 weeks gestation)
- Subject is in general good health
- Written informed consent and HIPAA authorization (if applicable) obtained from the subject's legal representative
- Subject's legal representative is willing and able to bring the subject to the study site for evaluation of respiratory illness in accordance with the protocol

Exclusion Criteria

- Any fever (≥ 100.4°F [≥ 38.0°C]), regardless of route within 7 days prior to randomization
- Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization
- Moderate or severe nasal congestion that in the investigator's opinion could prevent intranasal delivery of vaccine
- Cohort 1 only: weight ≤ 5th percentile for age on the day of randomization
- Cohort 2 only: history of low birth weight (ie, <2500 grams at birth) or weight ≤ 5th percentile for age on the day of randomization
- Living in the same home or enrolled in the same classroom at day care with infants <6 months of age within 28 days after each dose (only one child per household may be enrolled into the study)
- Contact with pregnant caregiver within 28 days after each dose
- Living in a household with someone who is immunocompromised within 28 days after each dose; the subject should also avoid close contact with immunocompromised individuals for at least 28 days after each study vaccine dosing
- Living in a household with someone who works in the healthcare field and who has direct patient care responsibilities within 28 days after each dose
- Living in a household with someone who is a day care provider or preschool teacher for children <6 months of age within 28 days after each dose

No locations available

Arms	Assigned Interventions
Experimental: Cohort 1 MEDI-559 MEDI-559	Biological/Vaccine: MEDI-559 Cohort 1 (5 to <24 months): N=80 MEDI-559 at 10^5 FFU at 0, 2, and 4 months; frozen preparation filled into 0.5 ml luer slip-tip syringes. Each 0.2 ml dose contains 10^5 FFU MEDI-559 in a sucrose phosphate glutamate buffer.
Placebo Comparator: Cohort 1 Placebo Placebo	Other: Placebo Cohort 1 (5 to < 24 months); N = 80 placebo at 0, 2, and 4 months; frozen preparation filled into 0.5 ml luer slip-tip syringes. Each 0.2 ml dose contains sucrose phosphate buffer.

Documents available

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MEDI-559_CP-147_Protocol_Redacted_13Nov13.pdf
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Trial Results Summaries
Available here

Contacts

Contact

Helene Mortimer

301-398-4814

[email protected]

Contact Backup

Joe Coffie

301-398-4723

Investigators

Principal Investigator

Joseph Sliman

MedImmune LLC