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COMPLETEDPHASE1

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

A Phase 1, 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 (PIV), in Healthy Children 6 to <24 Months of Age

NCT00493285•MedImmune LLC

View on ClinicalTrials.gov

Summary

The overall objective of the MEDI-534 clinical development program is to evaluate the safety, efficacy and tolerability of MEDI-534 for the prevention of serious RSV and PIV3 disease in young infants.

Detailed Description

The primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 at 10\^4, 10\^5, or 10\^6 TCID50 when administered to RSV and PIV3 seronegative children 6 to \<24 months of age.

Eligibility

Age

0 - 1 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male or female whose age on the day of randomization is 6 to \<24 months (reached 6th month birthday and not yet reached 2nd year birthday)
•Subject is seronegative to both RSV and PIV3 at screening
•Subject was the product of normal full term pregnancy (defined as \>36 weeks gestation)
•Subject is in general good health
•Subject's legal representative is available by telephone
•Written informed consent and HIPAA authorization (if applicable) obtained from the subject's legal representative
•Subject's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator
•Subject is available to complete the follow-up period, which will be through the end of RSV season (provisionally defined as 01/Apr for the United States) or 180 days after the final dose of study vaccine, whichever is later
•Subject's legal representative must be 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 (equal to or greater than 100.4°F \[equal to or greater than 38.0°C\], regardless of route) or lower respiratory illness (Section 4.1.2) within 7 days prior to randomization
•Moderate or severe nasal congestion that in the investigator's opinion could prevent intranasal delivery of vaccine
•Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt through the protocol-specified blood collection 28 days after each study vaccine dosing, except that infrequent use of over-the-counter medications such as pain relievers are permitted according to the judgment of the investigator
•Any current or expected receipt of immunosuppressive agents including steroids (2 mg/kg per day of prednisone or its equivalent, or equal to or greater than 20 mg/day if the subject weighs \>10 kg, given daily or on alternate days for equal to or greater than 14 days); children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for equal to or greater than 30 days; the use of topical steroids is permitted according to the judgment of the investigator
•History of receipt of blood transfusion or expected receipt through 30 days following final study vaccine dosing
•History of receipt of immunoglobulin products or expected receipt through 30 days after study vaccine dosing
•Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 30 days after final study vaccine dosing
•Receipt of any live virus vaccine (excluding rotavirus vaccine) within 28 days prior to randomization or expected receipt within a 28-day window around any study vaccine dose
•Receipt of any inactivated (i.e., non-live) vaccine or rotavirus vaccine within 14 days prior to randomization or expected receipt within a 14-day window around any study vaccine dose
•Known or suspected immunodeficiency, including HIV
+10 more criteria

Locations (30)

Arkansas Pediatric Research Division

Conway, Arkansas, United States

Arkansas Pediatric Clinic

Little Rock, Arkansas, United States

THe Children's Hospital

Aurora, Colorado, United States

Miami Children's Hospital

Miami, Florida, United States

Pediatric Partners

Palm Beach Gardens, Florida, United States

North Georgia Clinical Research Center

Dalton, Georgia, United States

University Consultants in Allergy and Immunology

Chicago, Illinois, United States

Children's Memorial Hospital

Chicago, Illinois, United States

University of Maryland, Baltimore

Baltimore, Maryland, United States

Tufts-New England Medical Center

Boston, Massachusetts, United States

Key Dates

Start Date

July 1, 2007

Primary Completion Date

November 1, 2009

Completion Date

April 1, 2010

Last Updated

July 19, 2012

Enrollment

ACTUAL participants

Conditions

Respiratory Viral InfectionsRespiratory Syncytial Virus InfectionsParainfluenza Virus 3, Human

Interventions

MEDI-534

BIOLOGICAL

MEDI-534

BIOLOGICAL

MEDI-534

BIOLOGICAL

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

NCT07220109

Respiratory Syncytial Virus Infections

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RECRUITINGPHASE2

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

NCT07092865

Respiratory Syncytial Virus Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 19, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

Genotype and Disease Burden of RSV in Older Vietnamese Adults (RSV: Respiratory Syncytial Virus )

An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study

Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children

MxA-Guided Antiviral Treatment in Respiratory Viral Infections