MedDataX Logo

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

NCT ID: NCT00767416

Last Updated: 2016-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to describe the 28-day post-final dose safety and tolerability of three doses of MEDI-559 at 10\^5 FFU when administered to healthy RSV seronegative children 1 to \<24 months of age.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Evaluate the Safety of MEDI-534 Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3) in Healthy Children

NCT00345670

Healthy
COMPLETED PHASE1

A Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to <24 Month-old Children and in 2 Month-old Infants

NCT00686075

Healthy
COMPLETED PHASE1/PHASE2

Evaluating the Safety and Immune Response to a Respiratory Syncytial Virus (RSV) Vaccine in Adults, RSV-Seropositive Children, and RSV-Seronegative Infants and Children

NCT01459198

Respiratory Syncytial Virus Infections
COMPLETED PHASE1

Safety and Tolerability Study to Evaluate MEDI-534 in Children 6 to < 24 Months of Age

NCT00493285

Respiratory Viral Infections Respiratory Syncytial Virus Infections Parainfluenza Virus 3, Human
COMPLETED PHASE1

Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID/ΔM2-2/1030s, in RSV-Seronegative Infants and Children 6 to 24 Months of Age

NCT04520659

RSV Infection
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a randomized, double-blind, placebo-controlled, multi-dose, Phase 1/2a multi-center trial to evaluate the safety, tolerability, viral shedding, immunogenicity, and genotypic and phenotypic stability of MEDI-559 in RSV seronegative infants 5 to \<24 months of age and in infants 1 to \<3 months of age regardless of baseline serostatus. The primary objective of this study is to describe the 28-day post-final dose safety and tolerability of three doses of MEDI-559 at 10\^5 FFU when administered to healthy RSV seronegative children 5 to \<24 months of age and to healthy infants 1 to \<3 months of age regardless of baseline serostatus.

MEDI-559 will be administered at a dose of 10\^5 fluorescent focus units (FFU) on a 0, 2, and 4 month schedule to two cohorts of subjects in a step-wise fashion. The target sample size for this study is 320 subjects, with 160 subjects 5 to \<24 months of age enrolled into Cohort 1 and 160 subjects 1 to \<3 months of age enrolled into Cohort 2. Each cohort will be randomized 1:1 (MEDI-559 to placebo) and stratified by site. Cohort 1 will initiate dosing at 10\^5 FFU MEDI-559. Blinded safety data from the first 40 subjects enrolled in Cohort 1 for the 28 days following administration of the first dose of vaccine will be reviewed. If no safety concerns are noted, Cohort 2 will initiate dosing at 10\^5 FFU. Enrollment into Cohort 2 will be halted after approximately 40 subjects have been randomized, and blinded safety data will be reviewed through 28 days post Dose 1. If no safety concerns are noted, the remainder of Cohort 2 will be enrolled. All subjects will be followed through 365 days after randomization to ensure that each subject has been followed through an RSV season.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1 MEDI-559

MEDI-559

Group Type EXPERIMENTAL

MEDI-559

Intervention Type BIOLOGICAL

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.

Cohort 1 Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BIOLOGICAL

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Month

Maximum Eligible Age

23 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

MedImmune LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joseph Sliman, M.D.

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Greenville, Alabama, United States

Site Status

Research Site

Huntsville, Alabama, United States

Site Status

Research Site

Mobile, Alabama, United States

Site Status

Research Site

Conway, Arkansas, United States

Site Status

Research Site

Little Rock, Arkansas, United States

Site Status

Research Site

Little Rock, Arkansas, United States

Site Status

Research Site

Anaheim, California, United States

Site Status

Research Site

Cypress, California, United States

Site Status

Research Site

Downey, California, United States

Site Status

Research Site

Huntington Beach, California, United States

Site Status

Research Site

Lakewood, California, United States

Site Status

Research Site

Long Beach, California, United States

Site Status

Research Site

Los Angeles, California, United States

Site Status

Research Site

Los Angeles, California, United States

Site Status

Research Site

Paramount, California, United States

Site Status

Research Site

San Diego, California, United States

Site Status

Research Site

Santa Ana, California, United States

Site Status

Research Site

Thornton, Colorado, United States

Site Status

Research Site

Hartford, Connecticut, United States

Site Status

Research Site

Washington D.C., District of Columbia, United States

Site Status

Research Site

Miami, Florida, United States

Site Status

Research Site

Miami, Florida, United States

Site Status

Research Site

Orange City, Florida, United States

Site Status

Research Site

Tampa, Florida, United States

Site Status

Research Site

Dalton, Georgia, United States

Site Status

Research Site

Chicago, Illinois, United States

Site Status

Research Site

Fishers, Indiana, United States

Site Status

Research Site

New Albany, Indiana, United States

Site Status

Research Site

South Bend, Indiana, United States

Site Status

Research Site

Ames, Iowa, United States

Site Status

Research Site

Bardstown, Kentucky, United States

Site Status

Research Site

Lexington, Kentucky, United States

Site Status

Research Site

Lexington, Kentucky, United States

Site Status

Research Site

Louisville, Kentucky, United States

Site Status

Research Site

Louisville, Kentucky, United States

Site Status

Research Site

Paducah, Kentucky, United States

Site Status

Research Site

Metarie, Louisiana, United States

Site Status

Research Site

Fredrick, Maryland, United States

Site Status

Research Site

Boston, Massachusetts, United States

Site Status

Research Site

Fall River, Massachusetts, United States

Site Status

Research Site

Bridgeton, Missouri, United States

Site Status

Research Site

Kansas City, Missouri, United States

Site Status

Research Site

Omaha, Nebraska, United States

Site Status

Research Site

Omaha, Nebraska, United States

Site Status

Research Site

Brooklyn, New York, United States

Site Status

Research Site

Endwell, New York, United States

Site Status

Research Site

Stony Brook, New York, United States

Site Status

Research Site

Syracuse, New York, United States

Site Status

Research Site

Cleveland, Ohio, United States

Site Status

Research Site

Cleveland, Ohio, United States

Site Status

Research Site

Huber Heights, Ohio, United States

Site Status

Research Site

Norman, Oklahoma, United States

Site Status

Research Site

Tulsa, Oklahoma, United States

Site Status

Research Site

Warwick, Rhode Island, United States

Site Status

Research Site

Spartanburg, South Carolina, United States

Site Status

Research Site

Franklin, Tennessee, United States

Site Status

Research Site

Jackson, Tennessee, United States

Site Status

Research Site

Johnson City, Tennessee, United States

Site Status

Research Site

Kingsport, Tennessee, United States

Site Status

Research Site

Corpus Christi, Texas, United States

Site Status

Research Site

Houston, Texas, United States

Site Status

Research Site

Houston, Texas, United States

Site Status

Research Site

San Angelo, Texas, United States

Site Status

Research Site

San Antonio, Texas, United States

Site Status

Research Site

San Antonio, Texas, United States

Site Status

Research Site

San Antonio, Texas, United States

Site Status

Research Site

Tomball, Texas, United States

Site Status

Research Site

Layton, Utah, United States

Site Status

Research Site

St. George, Utah, United States

Site Status

Research Site

Syracuse, Utah, United States

Site Status

Research Site

Charlottesville, Virginia, United States

Site Status

Research Site

Colonial Heights, Virginia, United States

Site Status

Research Site

Midlothian, Virginia, United States

Site Status

Research Site

Richmond, Virginia, United States

Site Status

Research Site

Walla Walla, Washington, United States

Site Status

Research Site

Caguas, , Puerto Rico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Puerto Rico

References

Explore related publications, articles, or registry entries linked to this study.

Malkin E, Yogev R, Abughali N, Sliman J, Wang CK, Zuo F, Yang CF, Eickhoff M, Esser MT, Tang RS, Dubovsky F. Safety and immunogenicity of a live attenuated RSV vaccine in healthy RSV-seronegative children 5 to 24 months of age. PLoS One. 2013 Oct 29;8(10):e77104. doi: 10.1371/journal.pone.0077104. eCollection 2013.

Reference Type DERIVED
PMID: 24204744 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=12&filename=MEDI-559_CP-147_Protocol_Redacted_13Nov13.pdf

MEDI-559\_CP-147\_Protocol\_Redacted\_13Nov13

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MI-CP147

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months
NCT04909021 UNKNOWN PHASE1
Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine in RSV-Seronegative Infants 6 to 24 Months of Age
NCT02794870 COMPLETED PHASE1
Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in Infants and Children
NCT01893554 UNKNOWN PHASE1
A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness
NCT00421304 COMPLETED NA
Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children
NCT03596801 COMPLETED PHASE1
Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age
NCT03916185 TERMINATED PHASE1/PHASE2
Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children
NCT01852266 COMPLETED PHASE1
Intranasal Challenge of Healthy Adults With Respiratory Syncytial Virus (RSV)
NCT01475305 TERMINATED PHASE1
Evaluating the Infectivity, Safety, and Immunogenicity of Recombinant Live-Attenuated RSV Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants 6 to 24 Months of Age
NCT03227029 COMPLETED PHASE1
Safety and Immune Response to an Investigational Vaccine Against Respiratory Syncytial Virus in Healthy Adults
NCT04227210 COMPLETED PHASE1
Evaluating the Infectivity, Safety, and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine in RSV-Seronegative Infants and Children 6 to 24 Months of Age
NCT02952339 COMPLETED PHASE1
MEDI-557 Adult Dosing
NCT01562938 COMPLETED PHASE1
Safety and Immunogenicity of the RSV D46cpΔM2-2 Vaccine in RSV-Seropositive Children and RSV-Seronegative Infants and Children
NCT02601612 COMPLETED PHASE1
Study of the Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seropositive Children
NCT04444284 COMPLETED PHASE1
A Study to Evaluate the Safety of the Respiratory Syncytial Virus Vaccine MEDI7510 in Older Adults
NCT02115815 COMPLETED PHASE1
Evaluating the Infectivity, Safety, and Immunogenicity of a Respiratory Syncytial Virus Vaccine (RSV 6120/∆NS2/1030s) in RSV-Seropositive Children and RSV-Seronegative Infants and Children
NCT03387137 COMPLETED PHASE1
Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children
NCT02040831 COMPLETED PHASE1
Evaluating the Infectivity, Safety, and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (D46/NS2/N/ΔM2-2-HindIII) in RSV-Seronegative Infants 6 to 24 Months of Age
NCT03102034 COMPLETED PHASE1
Evaluation of the Safety and Immunogenicity of a Live Attenuated Human Metapneumovirus Vaccine
NCT01255410 COMPLETED PHASE1
A Study to Evaluate the Efficacy of MEDI7510 in Older Adults
NCT02508194 TERMINATED PHASE2
A Study to Learn About the Safety and Immune Activity of RSVpreF in Children 2 to <18 Years of Age
NCT05900154 COMPLETED PHASE1
Safety and Immunogenicity of an Intranasal RSV Vaccine Expressing SARS-CoV-2 Spike Protein (COVID-19 Vaccine) in Adults
NCT04798001 UNKNOWN PHASE1
A Phase 2 Study to Describe the Safety and Immunogenicity of Respiratory Syncytial Virus Vaccine IN006 in Healthy Participants Aged 60 Years and Older
NCT07128121 ACTIVE_NOT_RECRUITING PHASE2
Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children
NCT02237209 COMPLETED PHASE1
Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children
NCT01968083 COMPLETED PHASE1