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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00686075




Registration number
NCT00686075
Ethics application status
Date submitted
23/05/2008
Date registered
29/05/2008
Date last updated
26/09/2014

Titles & IDs
Public title
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
Scientific title
A Phase 1/2a, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, a Live, Attenuated Intranasal Vaccine 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
Secondary ID [1] 0 0
MI-CP178
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - MEDI-534, Cohort 1
Other interventions - Placebo, Cohort 1
Treatment: Other - MEDI-534, Cohort 2
Other interventions - Placebo, Cohort 2
Treatment: Other - MEDI-534, Cohort 3
Other interventions - Placebo, Cohort 3
Treatment: Other - MEDI-534, Cohort 4
Other interventions - Placebo, Cohort 4
Treatment: Other - MEDI-534, Cohort 5
Other interventions - Placebo, Cohort 5

Experimental: MEDI-534, Cohort 1 - Participants aged 6 to less than (\<) 24 months will receive MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.

Placebo comparator: Placebo, Cohort 1 - Participants aged 6 to \<24 months will receive placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.

Experimental: MEDI-534, Cohort 2 - Participants aged 6 to \<24 months will receive MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.

Placebo comparator: Placebo, Cohort 2 - Participants aged 6 to \<24 months will receive placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.

Experimental: MEDI-534, Cohort 3 - Participants aged 2 months will receive MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.

Placebo comparator: Placebo, Cohort 3 - Participants aged 2 months will receive placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.

Experimental: MEDI-534, Cohort 4 - Participants aged 2 months will receive MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.

Placebo comparator: Placebo, Cohort 4 - Participants aged 2 months will receive placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.

Experimental: MEDI-534, Cohort 5 - Participants aged 2 months will receive MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.

Placebo comparator: Placebo, Cohort 5 - Participants aged 2 months will receive placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.


Treatment: Other: MEDI-534, Cohort 1
Participants aged 6 to less than (\<) 24 months will receive MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.

Other interventions: Placebo, Cohort 1
Participants aged 6 to \<24 months will receive placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.

Treatment: Other: MEDI-534, Cohort 2
Participants aged 6 to \<24 months will receive MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.

Other interventions: Placebo, Cohort 2
Participants aged 6 to \<24 months will receive placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.

Treatment: Other: MEDI-534, Cohort 3
Participants aged 2 months will receive MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.

Other interventions: Placebo, Cohort 3
Participants aged 2 months will receive placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.

Treatment: Other: MEDI-534, Cohort 4
Participants aged 2 months will receive MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.

Other interventions: Placebo, Cohort 4
Participants aged 2 months will receive placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.

Treatment: Other: MEDI-534, Cohort 5
Participants aged 2 months will receive MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.

Other interventions: Placebo, Cohort 5
Participants aged 2 months will receive placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Solicited Symptoms After Dose 1
Timepoint [1] 0 0
Within 28 days after Dose 1
Primary outcome [2] 0 0
Number of Participants With Solicited Symptoms After Dose 2
Timepoint [2] 0 0
Within 28 days after Dose 2
Primary outcome [3] 0 0
Number of Participants With Solicited Symptoms After Dose 3
Timepoint [3] 0 0
Within 28 days after Dose 3
Primary outcome [4] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 1
Timepoint [4] 0 0
Within 28 days after Dose 1
Primary outcome [5] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 2
Timepoint [5] 0 0
Within 28 days after Dose 2
Primary outcome [6] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 3
Timepoint [6] 0 0
Within 28 days after Dose 3
Primary outcome [7] 0 0
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 1
Timepoint [7] 0 0
Within 28 days after Dose 1
Primary outcome [8] 0 0
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 2
Timepoint [8] 0 0
Within 28 days after Dose 2
Primary outcome [9] 0 0
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 3
Timepoint [9] 0 0
Within 28 days after Dose 3
Primary outcome [10] 0 0
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1
Timepoint [10] 0 0
Within 28 days after Dose 1
Primary outcome [11] 0 0
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 2
Timepoint [11] 0 0
Within 28 days after Dose 2
Primary outcome [12] 0 0
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 3
Timepoint [12] 0 0
Within 28 days after Dose 3
Secondary outcome [1] 0 0
Number of Participants Who Shed Vaccine-Type Virus
Timepoint [1] 0 0
7, 12 and 28 days after Dose 1, 2 and 3
Secondary outcome [2] 0 0
Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3
Timepoint [2] 0 0
Day 28 after Dose 3
Secondary outcome [3] 0 0
Genotypic Stability of Recovered Vaccine-Type Virus
Timepoint [3] 0 0
Within 28 days after any dose
Secondary outcome [4] 0 0
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After Randomization
Timepoint [4] 0 0
Day 0 to Day 365
Secondary outcome [5] 0 0
Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization
Timepoint [5] 0 0
Day 0 to Day 365
Secondary outcome [6] 0 0
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization
Timepoint [6] 0 0
Day 0 to Day 365

Eligibility
Key inclusion criteria
* Male or female whose age on the day of randomization falls within one of the two age groups:

6 to less than (<) 24 months (more than [>] 6 months of age and not yet reached their 2nd year birthday), Cohorts 1 and 2 2 months (+/- 4 weeks), Cohorts 3, 4, and 5
* Cohorts 1 and 2 only: Subject is seronegative to both Respiratory Syncytial Virus (RSV) and human Parainfluenza Virus Type 3 (hPIV3) at Screening
* Subject whose gestational age was greater than or equal to (>=) 36 weeks
* Subject is in general good health with normal growth (that is, body weight greater than (>) third percentile per world health organization [WHO] simplified weight-per-age field tables
* Subject's legal representative is available by telephone
* Written informed consent and Health Insurance Portability and Accountability Act (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 1-year after receipt of the first dose of study vaccine
* 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.
Minimum age
2 Months
Maximum age
23 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Any fever (>=100.4 degrees Fahrenheit [>=38.0 degrees Celsius], regardless of route) or lower respiratory illness within 7 days prior to randomization
* Moderate or severe nasal congestion that in the investigator's opinion could interfere with intranasal delivery of study vaccine
* Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization
* 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 for the systemic treatment of common childhood symptoms (that is, pain relievers, decongestants or cough suppressants) are permitted according to the judgment of the investigator
* Any current or expected receipt of immunosuppressive agents including steroids (>=2 milligram per kilogram [mg/kg] per day of prednisone or its equivalent, or >=20 milligram per day [mg/day] if the subject weighs >10 kilogram [kg], given daily or on alternate days for >=14 days); children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for >=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 the protocol-specified blood collection at 28 days after final study dosing
* History of receipt of immunoglobulin products or expected receipt through the protocol-specified blood collection at 28 days after final study dosing
* Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 180 days after final study dosing
* Receipt of any live virus vaccine (excluding oral polio vaccine and 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 (that is, non-live) vaccine or oral polio 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 human immunodeficiency virus (HIV) infection
* Expected to be living in the same home or enrolled in the same classroom at day care with infants <6 months within 28 days after each dose
* Living in a household with another child who is concurrently enrolled in a study of a live viral vaccine (including this study)
* Expected contact with a pregnant caregiver within 28 days after each dose
* A household contact who is immunocompromised; the subject should also avoid close contact with immunocompromised individuals for at least 28 days after any study vaccine dose
* Expected household contact within 28 days after each dose with a health care provider for immunocompromised subjects 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 for respiratory illness (excludes elective mechanical ventilation during surgery for subjects in Cohorts 1 and 2)
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2012
Sample size
Target
Accrual to date
Final
1338
Recruitment in Australia
Recruitment state(s)
ACT,QLD,SA,WA
Recruitment hospital [1] 0 0
Research Site - Garran
Recruitment hospital [2] 0 0
Research Site - Herston
Recruitment hospital [3] 0 0
Research Site - North Adelaide
Recruitment hospital [4] 0 0
Research Site - Subiaco
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
4006 - Herston
Recruitment postcode(s) [3] 0 0
5006 - North Adelaide
Recruitment postcode(s) [4] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oregon
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
West Virginia
Country [25] 0 0
Brazil
State/province [25] 0 0
Rio Grande do Sul
Country [26] 0 0
Brazil
State/province [26] 0 0
SP
Country [27] 0 0
Brazil
State/province [27] 0 0
Porto alegre - RS
Country [28] 0 0
Brazil
State/province [28] 0 0
Porto Alegre/RS
Country [29] 0 0
Brazil
State/province [29] 0 0
Ribeirao Preto - SP
Country [30] 0 0
Brazil
State/province [30] 0 0
Sao Paulo - SP
Country [31] 0 0
Brazil
State/province [31] 0 0
São Paulo
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Canada
State/province [33] 0 0
Saskatchewan
Country [34] 0 0
Finland
State/province [34] 0 0
Helsinki
Country [35] 0 0
Finland
State/province [35] 0 0
Jarvenpaa
Country [36] 0 0
Finland
State/province [36] 0 0
Kokkola
Country [37] 0 0
Finland
State/province [37] 0 0
Kuopio
Country [38] 0 0
Finland
State/province [38] 0 0
Lahti
Country [39] 0 0
Finland
State/province [39] 0 0
Oulu
Country [40] 0 0
Finland
State/province [40] 0 0
Pori
Country [41] 0 0
Finland
State/province [41] 0 0
Tampere
Country [42] 0 0
Finland
State/province [42] 0 0
Turku
Country [43] 0 0
Germany
State/province [43] 0 0
Berlin
Country [44] 0 0
Germany
State/province [44] 0 0
Freiburg
Country [45] 0 0
Germany
State/province [45] 0 0
Mainz
Country [46] 0 0
Israel
State/province [46] 0 0
Netanya
Country [47] 0 0
South Africa
State/province [47] 0 0
Gauteng
Country [48] 0 0
South Africa
State/province [48] 0 0
Western Cape
Country [49] 0 0
Spain
State/province [49] 0 0
Andalucia
Country [50] 0 0
Spain
State/province [50] 0 0
Andalucía
Country [51] 0 0
Spain
State/province [51] 0 0
Cataluna
Country [52] 0 0
Spain
State/province [52] 0 0
Comunidad Valenciana
Country [53] 0 0
Spain
State/province [53] 0 0
Galicia
Country [54] 0 0
Spain
State/province [54] 0 0
Madrid, Communidad de
Country [55] 0 0
Spain
State/province [55] 0 0
Pais Vasco
Country [56] 0 0
Spain
State/province [56] 0 0
Esplugues de Llobregat
Country [57] 0 0
Spain
State/province [57] 0 0
Madrid
Country [58] 0 0
Spain
State/province [58] 0 0
Málaga
Country [59] 0 0
Spain
State/province [59] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MedImmune LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Elissa Malkin, D.O.
Address 0 0
MedImmune LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00686075