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

Primary Purpose

Healthy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MEDI-534
MEDI-534
MEDI-534
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy focused on measuring Lower respiratory tract illness, RSV and PIV3 infection

Eligibility Criteria

1 Year - 9 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Male or female aged 1 through 9 years old In general good health Seropositive for RSV (enzyme-linked immunosorbent assay [ELISA] titer > 12 U/ml) and PIV3 (hemagglutination-inhibition [HAI] titer > 1:8) Subject's parent/legal representative available by telephone Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (if applicable) obtained from the subject's parent/legal representative Ability of the subject's parent/legal representative to understand and comply with the requirements of the protocol as judged by the investigator Ability to complete the follow-up period of 6 months following dosing as required by the protocol Exclusion Criteria: Any fever and/or respiratory illness (e.g., cough or sore throat) within 7 days prior to randomization Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt of such therapy through the protocol-specified blood collection 28-35 days after study vaccine dosing Any current or expected receipt of systemic immunosuppressive agents including steroids; children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for less than or equal to 30 days Receipt of blood transfusion within 7 months prior to randomization or expected receipt through 35 days after study vaccine dosing Receipt of immunoglobulin products within 11 months prior to randomization or expected receipt through 35 days after study vaccine dosing Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 180 days after study vaccine dosing Receipt of any other live virus vaccine within 30 days prior to randomization or expected receipt through the protocol-specified blood collection 28-35 days after study vaccine dosing Receipt of any inactivated (i.e., non-live) vaccine within 14 days prior to randomization or expected receipt through the protocol-specified blood collection 28-35 days after study vaccine dosing History of Guillain-Barré syndrome Known or suspected immunodeficiency, including HIV Known or suspected acute or chronic hepatitis infection Living at home or attending day care with children less than or equal to 24 months of age Contact with pregnant caregiver Household contact who is immunocompromised; the subject should also avoid close contact with immunocompromised individuals for at least 30 days after study vaccine dosing History of hypersensitivity to kanamycin or other aminoglycoside antibiotics (gentamicin, tobramycin, etc) Previous medical history, or evidence, of chronic illness may compromise the safety of the subject At screening any of the following laboratory tests outside of the laboratory normal range: complete blood count (CBC) with differential and platelet count, AST, ALT, blood urea nitrogen (BUN), creatinine, or other abnormal laboratory value in the screening panel that, in the opinion of the principal investigator, is considered to be clinically significant or may potentially compromise the safety of the subject during the conduct of the study History of medically confirmed diagnosis of asthma, reactive airway disease, or chronic obstructive pulmonary disease (COPD) Passive primary household smoking Family member or household contact who is an employee of the research center with the conduct of the study Any condition that, in the opinion of the investigator, might interfere with study vaccine evaluation

Sites / Locations

  • Edinger Medical Group
  • Heart of America Research
  • Heart of America Research
  • Kentucky Pediatric/Adult Research
  • Cincinnati Children's Hospital Medical Center, Division of Infectious Disease
  • University of Maryland Pediatric Ambulatory Center
  • Meridian Clinical Research, LLC
  • Regional Clinical Research, Inc.
  • Children's Hospital at Montefiore; Montefiore Medical Center
  • Pediatric Associates of Mt. Carmel, Inc.
  • Primary Physicians Research, Inc.
  • University Physicians Internal Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

MEDI-534

MEDI-534

MEDI-534

Outcomes

Primary Outcome Measures

To describe the safety and tolerability of 1-9 year old RSV and PIV3 seropositive children
Reactogenicity evaluations (REs) from administration of study vaccine through 28 days post-dosing
Adverse events (AEs) from administration of study vaccine through 28 post-dosing
Serious adverse events (SAEs) from administration of study vaccine through 28 days post-dosing

Secondary Outcome Measures

To describe the immunogenicity and viral shedding of MEDI-534
The viral shedding of MEDI-534 will be assessed by the absence or presence of vaccine-type virus from nasal swab and nasal wash samples

Full Information

First Posted
June 27, 2006
Last Updated
September 2, 2008
Sponsor
MedImmune LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00345670
Brief Title
Study to Evaluate the Safety of MEDI-534 Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3) in Healthy Children
Official Title
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, and Viral Shedding of MEDI-534, a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy RSV and PIV3 Seropositive 1-9 Year-Old Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MedImmune LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, double-blind, placebo-controlled, dose-escalation, Phase 1, multi-center study to evaluate the safety, tolerability, immunogenicity, and viral shedding of MEDI-534 in healthy children 1-9 years of age who are seropositive for respiratory syncytial virus (RSV) and parainfluenza virus type 3 (PIV3) at screening.
Detailed Description
This is a randomized, double-blind, placebo-controlled, dose-escalation Phase 1 multi-center study to evaluate the safety, tolerability, immunogenicity, and viral shedding of MEDI-534 in healthy children 1-9 years of age who are seropositive for RSV and PIV3 at screening. MEDI-534 will be administered at dosage levels of 10:4 TCID50, 10:5 TCID50, or 10:6 TCID50 to three cohorts of subjects in a staggered, step-wise fashion. A single dose of study vaccine (MEDI-534 or matched volume of vehicle placebo) will be administered on Study Day 0 by nasal spray, one-half dose into each nostril. The target sample size is 120 subjects randomized 1:1 (MEDI-534 to placebo), with 40 subjects in each of three cohorts. Randomization will be stratified by site. This study will enroll during the RSV off season at multiple sites in the United States and Chile.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Lower respiratory tract illness, RSV and PIV3 infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
MEDI-534
Arm Title
2
Arm Type
Experimental
Arm Description
MEDI-534
Arm Title
3
Arm Type
Experimental
Arm Description
MEDI-534
Intervention Type
Biological
Intervention Name(s)
MEDI-534
Intervention Description
10:4 TCID50 of MEDI-534 intranasal spray Study Day 0
Intervention Type
Biological
Intervention Name(s)
MEDI-534
Intervention Description
10:5 TCID50 of MEDI-534 intranasal spray Study Day 0
Intervention Type
Biological
Intervention Name(s)
MEDI-534
Intervention Description
10:6 TCID50 of MEDI-534; intranasal spray
Primary Outcome Measure Information:
Title
To describe the safety and tolerability of 1-9 year old RSV and PIV3 seropositive children
Time Frame
Day 28
Title
Reactogenicity evaluations (REs) from administration of study vaccine through 28 days post-dosing
Time Frame
Day 28 post final vaccination
Title
Adverse events (AEs) from administration of study vaccine through 28 post-dosing
Time Frame
Day 28 post final vaccination
Title
Serious adverse events (SAEs) from administration of study vaccine through 28 days post-dosing
Time Frame
Day 180
Secondary Outcome Measure Information:
Title
To describe the immunogenicity and viral shedding of MEDI-534
Time Frame
Days 3, 7, 14 days (± 1 day) and 28 35 days after study vaccine dosing as well as at any unscheduled study visits.
Title
The viral shedding of MEDI-534 will be assessed by the absence or presence of vaccine-type virus from nasal swab and nasal wash samples
Time Frame
Days 3, 7, 14 days (± 1 day) and 28 35 days after study vaccine dosing as well as at any unscheduled study visits.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female aged 1 through 9 years old In general good health Seropositive for RSV (enzyme-linked immunosorbent assay [ELISA] titer > 12 U/ml) and PIV3 (hemagglutination-inhibition [HAI] titer > 1:8) Subject's parent/legal representative available by telephone Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (if applicable) obtained from the subject's parent/legal representative Ability of the subject's parent/legal representative to understand and comply with the requirements of the protocol as judged by the investigator Ability to complete the follow-up period of 6 months following dosing as required by the protocol Exclusion Criteria: Any fever and/or respiratory illness (e.g., cough or sore throat) within 7 days prior to randomization Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt of such therapy through the protocol-specified blood collection 28-35 days after study vaccine dosing Any current or expected receipt of systemic immunosuppressive agents including steroids; children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for less than or equal to 30 days Receipt of blood transfusion within 7 months prior to randomization or expected receipt through 35 days after study vaccine dosing Receipt of immunoglobulin products within 11 months prior to randomization or expected receipt through 35 days after study vaccine dosing Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 180 days after study vaccine dosing Receipt of any other live virus vaccine within 30 days prior to randomization or expected receipt through the protocol-specified blood collection 28-35 days after study vaccine dosing Receipt of any inactivated (i.e., non-live) vaccine within 14 days prior to randomization or expected receipt through the protocol-specified blood collection 28-35 days after study vaccine dosing History of Guillain-Barré syndrome Known or suspected immunodeficiency, including HIV Known or suspected acute or chronic hepatitis infection Living at home or attending day care with children less than or equal to 24 months of age Contact with pregnant caregiver Household contact who is immunocompromised; the subject should also avoid close contact with immunocompromised individuals for at least 30 days after study vaccine dosing History of hypersensitivity to kanamycin or other aminoglycoside antibiotics (gentamicin, tobramycin, etc) Previous medical history, or evidence, of chronic illness may compromise the safety of the subject At screening any of the following laboratory tests outside of the laboratory normal range: complete blood count (CBC) with differential and platelet count, AST, ALT, blood urea nitrogen (BUN), creatinine, or other abnormal laboratory value in the screening panel that, in the opinion of the principal investigator, is considered to be clinically significant or may potentially compromise the safety of the subject during the conduct of the study History of medically confirmed diagnosis of asthma, reactive airway disease, or chronic obstructive pulmonary disease (COPD) Passive primary household smoking Family member or household contact who is an employee of the research center with the conduct of the study Any condition that, in the opinion of the investigator, might interfere with study vaccine evaluation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margarita M Gomez, M.D.
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
Edinger Medical Group
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Heart of America Research
City
Shawnee
State/Province
Kansas
ZIP/Postal Code
66216
Country
United States
Facility Name
Heart of America Research
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66614
Country
United States
Facility Name
Kentucky Pediatric/Adult Research
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center, Division of Infectious Disease
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
University of Maryland Pediatric Ambulatory Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Regional Clinical Research, Inc.
City
Binghamton
State/Province
New York
ZIP/Postal Code
13901
Country
United States
Facility Name
Children's Hospital at Montefiore; Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Pediatric Associates of Mt. Carmel, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Primary Physicians Research, Inc.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
University Physicians Internal Medicine
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701-3655
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19483659
Citation
Gomez M, Mufson MA, Dubovsky F, Knightly C, Zeng W, Losonsky G. Phase-I study MEDI-534, of a live, attenuated intranasal vaccine against respiratory syncytial virus and parainfluenza-3 virus in seropositive children. Pediatr Infect Dis J. 2009 Jul;28(7):655-8. doi: 10.1097/INF.0b013e318199c3b1.
Results Reference
derived

Learn more about this trial

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

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