HealthyPhase 1/2NCT00686075
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
A Phase 1/2 study testing MEDI-534, Cohort 1, MEDI-534, Cohort 2 and MEDI-534, Cohort 3 in people with Healthy, run by MedImmune LLC at 100 sites in 9 countries.
Trial summary
Primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 in children 6 to less than (<) 24 months of age and in infants 2 months of age. Read more about this study
- Who is it for?
- Ages 2 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MEDI-534, Cohort 1, MEDI-534, Cohort 2 and MEDI-534, Cohort 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,338 participants
- Where
- 100 sitesin 9 countries
- Study dates
- Jun 2008to Aug 2012
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 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 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
100 sites in 9 countries.
100 sites in 9 countries
United States51 sites
Research Site
Amarillo, Texas
Research Site
Anaheim, California, 92801
Research Site
Anaheim, California
Research Site
Bell Gardens, California, 90201
Research Site
Bentonville, Arkansas, 72712
Research Site
Bridgeton, Missouri, 63044
Research Site
Brooklyn, New York
Research Site
Chicago, Illinois, 60614
Research Site
Cincinnati, Ohio, 45229
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Dallas, Texas
Research Site
Dalton, Georgia, 30721
Research Site
Downey, California, 90241
Research Site
Gainesville, Florida, 32607
Research Site
Gresham, Oregon, 97030
Research Site
Houston, Texas, 77030
Research Site
Huntington, West Virginia, 25701
Research Site
Jackson, Tennessee, 38305
Research Site
Johnson City, New York
Research Site
Kansas City, Kansas
Research Site
Lake Success, New York, 11042
Research Site
Lakewood, California, 90712
Research Site
Las Vegas, Nevada
Research Site
Layton, Utah, 84041
Research Site
Lexington, Kentucky, 40503
Research Site
Little Rock, Arkansas, 72202
Research Site
Long Beach, California
Research Site
Midlothian, Virginia, 23113
Research Site
Mobile, Alabama
Research Site
New Bern, North Carolina, 28562
Research Site
Omaha, Nebraska, 68131
Research Site
Omaha, Nebraska, 68134
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Orem, Utah, 84058
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Paducah, Kentucky, 42003
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Paramount, California, 90723
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Pittsburgh, Pennsylvania
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Poteet, Texas
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Saint Paul, Minnesota, 55108
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San Antonio, Texas, 78229
Research Site
San Antonio, Texas, 78258
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San Antonio, Texas
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San Diego, California, 92103
Research Site
Sellersville, Pennsylvania, 18960
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Shreveport, Louisiana
Research Site
St. George, Utah, 84790
Research Site
Stony Brook, New York, 11794-8111
Research Site
Syracuse, New York, 13210
Research Site
Tampa, Florida, 33606
Research Site
Thornton, Colorado
Research Site
Tomball, Texas, 77070
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Topeka, Kansas, 66604
Research Site
West Covina, California, 91790
Spain19 sites
Research Site
Almería, Andalusia, 04007
Research Site
Almería, Andalusia, 04009
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Almería, Andalusia, 04120
Research Site
Barcelona, Catalonia, 08003
Research Site
Catarroja, Valencia, 46470
Research Site
Donostia / San Sebastian, Basque Country, 20014
Research Site
Esplugues de Llobregat
Research Site
Jerez de la Frontera, Andalusia, 11407
Research Site
La Eliana, Valencia, Valencia, 46183
Research Site
Madrid, Madrid, 28046
Research Site
Madrid, Madrid, Communidad de, 28041
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Málaga, Málaga, 29011
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Santiago de Compostela, Galicia, 15706
Research Site
Valencia, Valencia, 46017
Research Site
Valencia, Valencia, 46021
Research Site
Valencia, Valencia, 46022
Research Site
Valencia, Valencia, 46024
Research Site
Valencia, 46010
Research Site
Valencia, 46011
Finland9 sites
Research Site
Helsinki, FI-00930
Research Site
Jarvenpaa, 04400
Research Site
Kokkola, FI-67100
Research Site
Kuopio, FI-70211
Research Site
Lahti, FI-15140
Research Site
Oulu, FI-90220
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Pori, FI-28100
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Tampere, 33100
Research Site
Turku, FI-20520
Brazil7 sites
Research Site
Passo Fundo-RS, Rio Grande do Sul, 99010
Research Site
Porto Alegre - RS
Research Site
Porto Alegre/RS, 90035-903
Research Site
Ribeirao Preto - SP, 14048-990
Research Site
São Paulo, São Paulo, 05437-010
Research Site
São Paulo, 01221-020
Research Site
Sao Paulo - SP
Australia4 sites
Research Site
Garran, Australian Capital Territory, 2605
Research Site
Herston, Queensland, 4006
Research Site
North Adelaide, South Australia, 5006
Research Site
Subiaco, Western Australia, 6008
South Africa4 sites
Research Site
Belle Ville Cape Town, Western Cape, 7530
Research Site
Cape Town, Western Cape, 7824
Research Site
Johannesburg, Gauteng, 2013
Research Site
Pretoria, Gauteng, 0001
Germany3 sites
Research Site
Berlin, 10365
Research Site
Freiburg im Breisgau, 79106
Research Site
Mainz
Canada2 sites
Research Site
Brampton, Ontario, L6W3E1
Research Site
Saskatoon, Saskatchewan, S7N 0W8
About this study
Official 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
Primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 in children 6 to less than (<) 24 months of age and in infants 2 months of age.
Read the detailed description
This is a Phase 1/2a, randomized, double-blind, placebo-controlled, dose-escalation, multicenter study to evaluate the safety and tolerability of multiple doses of MEDI-534 at 10^5 or 10^6 median tissue culture infectious dose (TCID50) in RSV and PIV3 seronegative children 6 to <24 months of age and at dosages of 10^4, 10^5 or 10^6 TCID50 in unscreened infants 2 months of age.
- Conditions
- Healthy
- Being tested
- MEDI-534, Cohort 1, Placebo, Cohort 1, MEDI-534, Cohort 2, Placebo, Cohort 2, MEDI-534, Cohort 3
- Keywords
- Respiratory Syncytial Virus (RSV), Parainfluenza Virus Type 3 (PIV3), MEDI-534
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-534, Cohort 1Biological
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, Cohort 1Other
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.
MEDI-534, Cohort 2Biological
Participants aged 6 to <24 months will receive MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Placebo, Cohort 2Other
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.
MEDI-534, Cohort 3Biological
Participants aged 2 months will receive MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
Placebo, Cohort 3Other
Participants aged 2 months will receive placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
MEDI-534, Cohort 4Biological
Participants aged 2 months will receive MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
Placebo, Cohort 4Other
Participants aged 2 months will receive placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
MEDI-534, Cohort 5Biological
Participants aged 2 months will receive MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Placebo, Cohort 5Other
Participants aged 2 months will receive placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
| Study group | Role | What they receive |
|---|---|---|
| MEDI-534, Cohort 1 | Experimental | 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. Receives: Biological: MEDI-534, Cohort 1 |
| Placebo, Cohort 1 | Placebo comparator | 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. Receives: Other: Placebo, Cohort 1 |
| MEDI-534, Cohort 2 | Experimental | Participants aged 6 to <24 months will receive MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4. Receives: Biological: MEDI-534, Cohort 2 |
| Placebo, Cohort 2 | Placebo comparator | 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. Receives: Other: Placebo, Cohort 2 |
| MEDI-534, Cohort 3 | Experimental | Participants aged 2 months will receive MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4. Receives: Biological: MEDI-534, Cohort 3 |
| Placebo, Cohort 3 | Placebo comparator | Participants aged 2 months will receive placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4. Receives: Other: Placebo, Cohort 3 |
| MEDI-534, Cohort 4 | Experimental | Participants aged 2 months will receive MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4. Receives: Biological: MEDI-534, Cohort 4 |
| Placebo, Cohort 4 | Placebo comparator | Participants aged 2 months will receive placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4. Receives: Other: Placebo, Cohort 4 |
| MEDI-534, Cohort 5 | Experimental | Participants aged 2 months will receive MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4. Receives: Biological: MEDI-534, Cohort 5 |
| Placebo, Cohort 5 | Placebo comparator | Participants aged 2 months will receive placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4. Receives: Other: Placebo, Cohort 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Symptoms After Dose 1
Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever greater than or equal to (>=) 100.4 degrees Fahrenheit (F), runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
Measured: Within 28 days after Dose 1
Number of Participants With Solicited Symptoms After Dose 2
Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever >=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
Measured: Within 28 days after Dose 2
Number of Participants With Solicited Symptoms After Dose 3
Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever >=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
Measured: Within 28 days after Dose 3
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 1
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAEs) for Dose 1 are events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 1 were reported.
Measured: Within 28 days after Dose 1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 2
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 2 are events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 2 were reported.
Measured: Within 28 days after Dose 2
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 3
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 3 are events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 3 were reported.
Measured: Within 28 days after Dose 3
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 1
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 1 were reported.
Measured: Within 28 days after Dose 1
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 2
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 2 were reported.
Measured: Within 28 days after Dose 2
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 3
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 3 were reported.
Measured: Within 28 days after Dose 3
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1
An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.
Measured: Within 28 days after Dose 1
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 2
An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.
Measured: Within 28 days after Dose 2
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 3
An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.
Measured: Within 28 days after Dose 3
Secondary outcomes (6)
Number of Participants Who Shed Vaccine-Type Virus
Nasal wash specimens were collected to assess vaccine virus recovery in the upper respiratory tract on 7, 12 and 28 days after each dosing.
Measured: 7, 12 and 28 days after Dose 1, 2 and 3
Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3
Seroresponse was defined as a >=4-fold rise from Baseline in neutralizing antibody titer, regardless of Baseline serostatus. Respiratory Syncytial Virus (RSV) and hPIV3 antibody titers were determined by using microneutralization assay and hemagglutination inhibition assay, respectively. Clopper-pearson exact confidence interval was reported.
Measured: Day 28 after Dose 3
Genotypic Stability of Recovered Vaccine-Type Virus
Nasal wash samples with vaccine-type virus were evaluated for genotypic stability, defined as the presence of the entire RSV-Fusion (RSV F) insert based on the RSV F sequence results. If the insert was absent or truncated, the recovered virus was counted as genotypically unstable. Nasal wash samples were categorized as genotypically stable, genotypically unstable or undetermined genotypic stability.
Measured: Within 28 days after any dose
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After Randomization
An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea. MA-LRIs occurring within 28 days post any dose and after 28 days post any dose were summarized separately.
Measured: Day 0 to Day 365
Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization
An SNMC was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of SNMCs include diabetes, asthma, autoimmune disease (for example, lupus, rheumatoid arthritis), and neurological disease (for example, epilepsy, autism).
Measured: Day 0 to Day 365
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events after administration of drug which were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) within 365 days after randomization were reported.
Measured: Day 0 to Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2012
- Study completionAug 2012
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 HealthyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,338 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elissa Malkin, D.O., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686075
- Sponsor's protocol ID
- MI-CP178
- Status last verified
- Sep 2014
- First submitted
- 23 May 2008
- Last updated
- 26 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Yang CF, Wang CK, Malkin E, Schickli JH, Shambaugh C, Zuo F, Galinski MS, Dubovsky F; Study Group; Tang RS. Implication of respiratory syncytial virus (RSV) F transgene sequence heterogeneity observed in Phase 1 evaluation of MEDI-534, a live attenuated parainfluenza type 3 vectored RSV vaccine. Vaccine. 2013 Jun 10;31(26):2822-7. doi: 10.1016/j.vaccine.2013.04.006. Epub 2013 Apr 16.
PubMed 23602668
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00686075
- Acronym / sponsor ID
- MI-CP178
- Conditions
- Healthy
- Keywords
- Respiratory Syncytial Virus (RSV), Parainfluenza Virus Type 3 (PIV3), MEDI-534
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,338 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 29 May 2008 (estimated)
- Results
- Posted 26 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 in children 6 to less than (<) 24 months of age and in infants 2 months of age.
Detailed description
This is a Phase 1/2a, randomized, double-blind, placebo-controlled, dose-escalation, multicenter study to evaluate the safety and tolerability of multiple doses of MEDI-534 at 10^5 or 10^6 median tissue culture infectious dose (TCID50) in RSV and PIV3 seronegative children 6 to <24 months of age and at dosages of 10^4, 10^5 or 10^6 TCID50 in unscreened infants 2 months of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| MEDI-534, Cohort 1 | Experimental | Biological: MEDI-534, Cohort 1Participants 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, Cohort 1 | Placebo comparator | Other: Placebo, Cohort 1Participants aged 6 to <24 months will receive placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4. |
| MEDI-534, Cohort 2 | Experimental | Biological: MEDI-534, Cohort 2Participants aged 6 to <24 months will receive MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4. |
| Placebo, Cohort 2 | Placebo comparator | Other: Placebo, Cohort 2Participants aged 6 to <24 months will receive placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4. |
| MEDI-534, Cohort 3 | Experimental | Biological: MEDI-534, Cohort 3Participants aged 2 months will receive MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4. |
| Placebo, Cohort 3 | Placebo comparator | Other: Placebo, Cohort 3Participants aged 2 months will receive placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4. |
| MEDI-534, Cohort 4 | Experimental | Biological: MEDI-534, Cohort 4Participants aged 2 months will receive MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4. |
| Placebo, Cohort 4 | Placebo comparator | Other: Placebo, Cohort 4Participants aged 2 months will receive placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4. |
| MEDI-534, Cohort 5 | Experimental | Biological: MEDI-534, Cohort 5Participants aged 2 months will receive MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4. |
| Placebo, Cohort 5 | Placebo comparator | Other: Placebo, Cohort 5Participants aged 2 months will receive placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4. |
Who may qualify
- Ages
- 2 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI-534, Cohort 1Participants 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. | Biological | MEDI-534, Cohort 1 |
| Placebo, Cohort 1Participants aged 6 to <24 months will receive placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4. | Other | Placebo, Cohort 1 |
| MEDI-534, Cohort 2Participants aged 6 to <24 months will receive MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4. | Biological | MEDI-534, Cohort 2 |
| Placebo, Cohort 2Participants aged 6 to <24 months will receive placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4. | Other | Placebo, Cohort 2 |
| MEDI-534, Cohort 3Participants aged 2 months will receive MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4. | Biological | MEDI-534, Cohort 3 |
| Placebo, Cohort 3Participants aged 2 months will receive placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4. | Other | Placebo, Cohort 3 |
| MEDI-534, Cohort 4Participants aged 2 months will receive MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4. | Biological | MEDI-534, Cohort 4 |
| Placebo, Cohort 4Participants aged 2 months will receive placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4. | Other | Placebo, Cohort 4 |
| MEDI-534, Cohort 5Participants aged 2 months will receive MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4. | Biological | MEDI-534, Cohort 5 |
| Placebo, Cohort 5Participants aged 2 months will receive placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4. | Other | Placebo, Cohort 5 |
Primary outcome
Number of Participants With Solicited Symptoms After Dose 1
Time frame: Within 28 days after Dose 1
Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever greater than or equal to (>=) 100.4 degrees Fahrenheit (F), runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
Number of Participants With Solicited Symptoms After Dose 2
Time frame: Within 28 days after Dose 2
Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever >=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
Number of Participants With Solicited Symptoms After Dose 3
Time frame: Within 28 days after Dose 3
Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever >=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 1
Time frame: Within 28 days after Dose 1
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAEs) for Dose 1 are events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 1 were reported.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 2
Time frame: Within 28 days after Dose 2
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 2 are events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 2 were reported.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 3
Time frame: Within 28 days after Dose 3
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 3 are events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 3 were reported.
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 1
Time frame: Within 28 days after Dose 1
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 1 were reported.
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 2
Time frame: Within 28 days after Dose 2
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 2 were reported.
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 3
Time frame: Within 28 days after Dose 3
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 3 were reported.
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1
Time frame: Within 28 days after Dose 1
An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 2
Time frame: Within 28 days after Dose 2
An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 3
Time frame: Within 28 days after Dose 3
An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.
6 secondary outcomes
Number of Participants Who Shed Vaccine-Type Virus
Time frame: 7, 12 and 28 days after Dose 1, 2 and 3
Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3
Time frame: Day 28 after Dose 3
Genotypic Stability of Recovered Vaccine-Type Virus
Time frame: Within 28 days after any dose
Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After Randomization
Time frame: Day 0 to Day 365
Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization
Time frame: Day 0 to Day 365
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization
Time frame: Day 0 to Day 365
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23602668Yang CF, Wang CK, Malkin E, Schickli JH, Shambaugh C, Zuo F, Galinski MS, Dubovsky F; Study Group; Tang RS. Implication of respiratory syncytial virus (RSV) F transgene sequence heterogeneity observed in Phase 1 evaluation of MEDI-534, a live attenuated parainfluenza type 3 vectored RSV vaccine. Vaccine. 2013 Jun 10;31(26):2822-7. doi: 10.1016/j.vaccine.2013.04.006. Epub 2013 Apr 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elissa Malkin, D.O. study director
MedImmune LLC
100 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MEDI-534, Cohort 1, MEDI-534, Cohort 2 and MEDI-534, Cohort 3 in people with Healthy, run by MedImmune LLC at 100 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 100 sites in United States, Spain, Finland, Brazil, Australia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Solicited Symptoms After Dose 1 (time frame: Within 28 days after Dose 1). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00686075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2014.