Respiratory Viral InfectionsPhase 1CP149NCT00493285
Safety and Tolerability Study to Evaluate MEDI-534 in Children 6 to < 24 Months of Age
A Phase 1 study testing MEDI-534 in people with Respiratory Viral Infections and Respiratory Syncytial Virus Infections, run by MedImmune LLC at 30 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Viral Infections, Respiratory Syncytial Virus Infections, Parainfluenza Virus 3, Human
- What is being tested?
- MEDI-534
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 30 sitesUnited States
- Study dates
- Jul 2007to Apr 2010
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- Living in the same home or enrolled in the same classroom at day care with infants <24 months of age (only one child per household may be enrolled into the study)
- Contact with pregnant caregiver
- A household contact who is immunocompromised; the subject should also avoid close contact with immunocompromised individuals for at least 30 days after any study vaccine dose
- A household contact who is a health care provider in contact with immunocompromised patients or who is a day care provider for infants under the age of 6 months
- History of allergic reaction to any component of the study vaccine
- Previous medical history, or evidence, of an intercurrent or chronic illness that, in the opinion of the investigator, may compromise the safety of the subject
- Known or suspected active or chronic hepatitis infection
- History of medical diagnosis of asthma, reactive airway disease, wheezing requiring medication, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically confirmed apnea, hospitalization for respiratory illness or mechanical ventilation
- Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study
- Any condition that, in the opinion of the investigator, might interfere with study vaccine evaluation
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
THe Children's Hospital
Aurora, Colorado, 80045
University of Maryland, Baltimore
Baltimore, Maryland, 21201
United Medical Associates
Binghamton, New York, 13901
Tufts-New England Medical Center
Boston, Massachusetts, 02111
Craig A. Spiegel, MD
Bridgeton, Missouri, 63044
University Consultants in Allergy and Immunology
Chicago, Illinois, 60612
Children's Memorial Hospital
Chicago, Illinois, 61614
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
University Hospitals case Medical Center
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44109
Arkansas Pediatric Research Division
Conway, Arkansas, 72033
North Georgia Clinical Research Center
Dalton, Georgia, 30721
University of Texas Health Science Center of Houston Medical School
Houston, Texas, 77030
Marshall University Joan C. Edwards School of Medicine
Huntington, West Virginia, 25701
Arkansas Pediatric Clinic
Little Rock, Arkansas, 72205
Miami Children's Hospital
Miami, Florida, 33155
Withrop University Hospital
Mineola, New York, 11501
West Virginia University Health Science Center
Morgantown, West Virginia, 26506
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Bear Care Pediatrics
Ogden, Utah, 84405
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134
Pediatric Partners
Palm Beach Gardens, Florida, 33410
Primary Physicians Research, Inc.
Pittsburgh, Pennsylvania, 15241
Virginia Commonwealth University
Richmond, Virginia, 23219
Sanford Children's Specialty Clinic
Sioux Falls, South Dakota, 57117
Copperview Medical Center
South Jordan, Utah, 84095
Rockwood Clinic Research Center
Spokane, Washington, 99202
SUNY Upstate Medical University
Syracuse, New York, 13210
St. Vincent Mercy Medical Center Mercy Children's Hospital
Toledo, Ohio, 43608
Advanced Pediatrics
Vienna, Virginia, 22180
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Respiratory Viral Infections, Respiratory Syncytial Virus Infections, Parainfluenza Virus 3, Human
- Being tested
- MEDI-534
- Keywords
- Lower Respiratory Tract Illness, RSV and PIV3 infection
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-534Biological
Multiple doses of MEDI-534 or Placebo at 10^4 TCID50
MEDI-534Biological
Multiple doses of MEDI-534 or Placebo at 10 ^5 TCID50.
MEDI-534Biological
Multiple doses of MEDI-534 or Placebo at 10^6 TCID50.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | MEDI-534 at 10^4 TCID50 at 0, 2, and 4 months (Nasal spray) Receives: Biological: MEDI-534 |
| 2 | Active comparator | MEDI-534 at 10^5 TCID50 at 0, 2, and 4 months (Nasal Spray) Receives: Biological: MEDI-534 |
| 3 | Active comparator | MEDI-534 at 10^6 TCID50 at 0, 2, and 4 months (Nasal Spray) Receives: Biological: MEDI-534 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Adverse Events (SEs) After Dose 1
The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.
Measured: Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Number of Participants With SEs After Dose 2
The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.
Measured: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants With SEs After Dose 3
The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.
Measured: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of Participants With Adverse Events (AEs) After Dose 1
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.
Measured: Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Number of Participants With AEs After Dose 2
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.
Measured: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants With AEs After Dose 3
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.
Measured: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of Subjects With Medically-attended Lower Respiratory Illnesses (MA-LRIs)
An MA-LRI was a healthcare provider-confirmed diagnosis of 1 or more of the following: wheezing, pneumonia, croup, rhonchi (not cleared with cough or suctioning), rales, bronchitis, bronchiolitis, apnea.
Measured: Days 0 to 180 days after final dose or the end of the RSV season, whichever was later
Number of Participants With Serious Adverse Events (SAEs)
Events resulting in death; were life-threatening; resulted in inpatient hospitalization/prolongation of hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and may have jeopardized the participant and required medical/surgical intervention to prevent one of the above outcomes.
Measured: Days 0-28 after any dose
Number of Participants With Significant New Medical Conditions (SNMCs)
A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.
Measured: Day 0 through 180 days after the final dose or through the end of the RSV season, whichever was later
Secondary outcomes (27)
Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Measured: Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 28-34 days post each dose.
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Measured: Days 7-10 after Dose 1 (Dose 1 was on Day 0)
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Measured: Days 12-18 after Dose 1 (Dose 1 was on Day 0)
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Measured: Days 28-34 after Dose 1 (Dose 1 was on Day 0)
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Measured: Days 0-34 after Dose 1 (Dose 1 was on Day 0)
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Measured: Days 7-10 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Measured: Days 12-18 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Measured: Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Measured: Days 0-34 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Measured: Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Measured: Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Measured: Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3
Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.
Measured: Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Baseline
Pre-dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.
Measured: Baseline (Day 0 prior to Dose 1)
Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 1
Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.
Measured: Day 28-34 after Dose 1 (Dose 1 was on Day 0)
Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 2
Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.
Measured: Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 3
Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.
Measured: Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies to PIV3 at Baseline
Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.
Measured: Baseline (Day 0 prior to Dose 1)
Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 1
Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.
Measured: Day 28-34 after Dose 1 (Dose 1 was on Day 0)
Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 2
Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.
Measured: Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 3
Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.
Measured: Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of Participants With Seroresponse to RSV 28 Days After Dose 1
Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.
Measured: Days 28-34 after Dose 1 (Dose 1 was on Day 0)
Number of Participants With Seroresponse to RSV 28 Days After Dose 2
Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.
Measured: Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants With Seroresponse to RSV 28 Days After Dose 3
Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.
Measured: Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of Participants With Seroresponse to PIV3 28 Days After Dose 1
Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.
Measured: Days 28-34 after Dose 1 (Dose 1 was on Day 0)
Number of Participants With Seroresponse to PIV3 28 Days After Dose 2
Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.
Measured: Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants With Seroresponse to PIV3 28 Days After Dose 3
Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.
Measured: Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionNov 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Viral InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Elissa Malkin, D.O., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493285
- Sponsor's protocol ID
- MI-CP149
- Acronym
- CP149
- Status last verified
- Jul 2012
- First submitted
- 26 Jun 2007
- Last updated
- 19 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bernstein DI, Malkin E, Abughali N, Falloon J, Yi T, Dubovsky F; MI-CP149 Investigators. Phase 1 study of the safety and immunogenicity of a live, attenuated respiratory syncytial virus and parainfluenza virus type 3 vaccine in seronegative children. Pediatr Infect Dis J. 2012 Feb;31(2):109-14. doi: 10.1097/INF.0b013e31823386f1.
PubMed 21926667