HealthyPhase 1/2NCT00508651
A Phase 1/2A Study to Evaluate the Safety, Immunogenicity, and Shedding of MEDI-560 in Infants 1 to < 12 Months of Age
A Phase 1/2 study testing MEDI-560 in people with Healthy, run by MedImmune LLC at 23 sites in United States.
Trial summary
The primary objective of this study is to describe the safety and tolerability of 3 doses of MEDI-560 at 10^5 TCID50 when administered to children 6 to < 12 months of age who are HPIV3 (human parainfluenza virus type 3) seronegative at baseline and to infants 1 to < 3 months of age regardless of baseline serostatus. Read more about this study
- Who is it for?
- Ages 1 month to 11 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MEDI-560
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 23 sitesUnited States
- Study dates
- Oct 2007to Apr 2009
- 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 1 month to 11 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 cohorts:
- Cohort 1: 6 to < 12 months (≥ 6 months of age and not yet reached their 1st year birthday); Cohort 2: 1 to < 3 months (> 28 days of age and not yet reached their 3rd month birthday)
- Cohort 1 only: Participant is seronegative to HPIV3 at screening as determined by ELISA; or the legal representative is willing to provide access to data documenting that the participant was screened for another MedImmune trial after written informed consent was obtained, and that the participant is seronegative to HPIV3 within 21 days prior to randomization into MI-CP150 as determined by ELISA at MedImmune
- Participant was the product of a normal full term pregnancy, defined as 36-42 weeks gestation
- Participant is in general good health
- Participant's legal representative is available by telephone
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- Written informed consent and Health Insurance Portability and Accountability Act authorization (if applicable) obtained from the participant's legal representative
- Participant's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator
- Participant is available to complete the follow-up period of 180 days after the final dose of investigational product as required by the protocol
- Participant's legal representative is 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°F [≥ 38.0°C], 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 prevent intranasal delivery of investigational product
- Cohort 1 only: weight < the fifth percentile for age on the day of randomization
- Cohort 2 only: history of low birth-weight (ie, < 2,500 grams at birth) or weight < fifth percentile for age on the day 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 investigational product 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 ≥ 20 mg/day if the participant weighs >10 kg, given daily or on alternate days for ≥ 14 days); children in this category should not receive investigational product 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
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- History of receipt of blood transfusion or expected receipt through 30 days after final investigational product dosing
- History of receipt of immunoglobulin products or expected receipt through 30 days after final investigational product dosing
- Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 30 days after final investigational product 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 dose
- Receipt of any inactivated (eg, non-live) vaccine or rotavirus vaccine within 14 days prior to randomization or expected receipt within a 14-day window around any dose
- Known or suspected immunodeficiency, including human immunodeficiency virus
- Living in the same home or enrolled in the same classroom at day care with infants < 24 months of age within 28 days after each dose (only one child per household may be enrolled into the study)
- Contact with pregnant caregiver within 28 days after each dose
- Household contact with an immunocompromised person within 28 days after each dose; the participant should also avoid close contact with immunocompromised individuals for at least 28 days after each investigational product dose
- Household contact within 28 days after each dose with a healthcare worker who has direct patient care responsibilities or household contact within 28 days after each dose with someone who is a day care provider or preschool teacher for children < 24 months of age
- History of allergic reaction to any component of the investigational product
- Previous medical history or evidence of an intercurrent or chronic illness that, in the opinion of the investigator, may compromise the safety of the participant
- Known or suspected active or chronic hepatitis infection
- History of medical diagnosis of asthma, reactive airway disease, wheezing requiring medication, bronchoconstriction or treatment with a β2 agonist (eg, albuterol), cystic fibrosis, chronic lung disease of prematurity (eg, bronchopulmonary dysplasia), chronic pulmonary disease, medically confirmed apnea, hospitalization for respiratory illness or mechanical ventilation
- A family member or a 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 investigational product evaluation
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Children's Investigational Research Program
Bentonville, Arkansas, 72712
St. Luke's Hospital
Bethlehem, Pennsylvania, 18015
Tufts-New England Medical Center
Boston, Massachusetts, 02111
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Duke Health Center- Pickett Road
Durham, North Carolina, 27705
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826-1032
University Physicians Internal Medicine
Huntington, West Virginia, 25701
Holston Medical Group
Kingsport, Tennessee, 37660
Children's Lung Specialists Ltd.
Las Vegas, Nevada, 89107
Michael W. Simon, M.D.
Lexington, Kentucky, 40503
Arkansas Pediatric Clinic
Little Rock, Arkansas, 72205
Madera Family Medical Group
Madera, California, 93637
Miami Children's Hospital
Miami, Florida, 33155
Homestead Clinical Research
Naranja, Florida, 33032
Tulane University
New Orleans, Louisiana, 70112
Meridian Clinical Research LLC
Omaha, Nebraska, 68134
Belleview Pediactric Assoc.
Pittsburgh, Pennsylvania, 15202
Allergy Medical Group of the North Area
Roseville, California, 95678
Dixie Pediatrics
St. George, Utah, 84790
SUNY Upstate Medical University
Syracuse, New York, 13210
University of South Florida College of Medicine Department of Pediatrics
Tampa, Florida, 33606
Oklahoma State University Center for Health Sciences
Tulsa, Oklahoma, 74127
About this study
Official title: An Expanded Phase1/2a Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, and Viral Shedding of MEDI-560, A Live, Attenuated Recombinant Parainfluenza Virus Type 3 (PIV3) Vaccine, Administered Intranasally to Healthy Infants 1 to <12 Mos. of Age
The primary objective of this study is to describe the safety and tolerability of 3 doses of MEDI-560 at 10^5 TCID50 when administered to children 6 to < 12 months of age who are HPIV3 (human parainfluenza virus type 3) seronegative at baseline and to infants 1 to < 3 months of age regardless of baseline serostatus.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, multidose Phase 1/2a multicenter study designed to evaluate the safety, tolerability, viral shedding, immunogenicity, and genotypic and phenotypic stability of MEDI-560 in infants 1 to < 12 months of age. Three doses of MEDI-560 at a dosage level of 10^5 TCID50 were administered 0, 2, and 4 months after enrollment to a 30-participant cohort of 6 to < 12 month-old HPIV3 seronegative children randomized 2:1 to MEDI-560 vs placebo. A second 160-participant cohort of 1 to < 3 month-old infants not screened for baseline serostatus was planned but was not opened to enrollment for reasons other than safety. Participants were followed for safety through 180 days post last dose. Nasal wash specimens were collected at screening and Days 7, 12, and 28 following each dose and during unscheduled illness visits to assess vaccine virus shedding and genotypic and phenotypic stability of any shed vaccine virus. Blood was collected at screening to determine eligibility and prior to Dose 1 for baseline serostatus. Blood for assessment of antibodies to HPIV3 was collected approximately 7 to 12 days after Dose 1 and Dose 3 and 1 month after each dose for antibodies to PIV3.
- Conditions
- Healthy
- Being tested
- MEDI-560, Placebo
- Keywords
- parainfluenza virus, children, vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-560Biological
MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson^TM luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI-560 in a sucrose phosphate glutamate buffer.
PlaceboBiological
Placebo was a frozen preparation filled into Becton Dickinson^TM luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 MEDI-560 | Experimental | MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson^TM Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI-560 in a sucrose phosphate glutamate buffer. Receives: Biological: MEDI-560 |
| Cohort 1 Placebo | Placebo comparator | Placebo was a frozen preparation filled into Becton Dickinson^TM Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. Receives: Biological: Placebo |
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
Measured: Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Number of Participants With SEs After Dose 2
Measured: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants With SEs After Dose 3
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 Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1
Measured: Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Number of Participants With MA-LRIs After Dose 2
Measured: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants With MA-LRIs After Dose 3
Measured: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of Participants With Serious Adverse Events (SAEs) After Dose 1
Measured: Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Number of Participants With SAEs After Dose 2
One participant had event of pneumonia after Dose 2.
Measured: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants With SAEs After Dose 3
Measured: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
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 final dose
Secondary outcomes (22)
Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Measured: Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose.
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
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 culture positive for HPIV3 in which vaccine-like virus was identified.
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 culture positive for HPIV3 in which vaccine-like virus was identified.
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
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 culture positive for HPIV3 in which vaccine-like virus was identified.
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 culture positive for HPIV3 in which vaccine-like virus was identified.
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 culture positive for HPIV3 in which vaccine-like virus was identified.
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 culture positive for HPIV3 in which vaccine-like virus was identified.
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 culture positive for HPIV3 in which vaccine-like virus was identified.
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 culture positive for HPIV3 in which vaccine-like virus was identified.
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 culture positive for HPIV3 in which vaccine-like virus was identified.
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 culture positive for HPIV3 in which vaccine-like virus was identified.
Measured: Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of Participants With Hemagglutination Inhibition (HAI) Seroconversion/Seroresponse to HPIV3 28 Days After Dose 1
Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.
Measured: Days 28-34 after Dose 1 (Dose 1 was on Day 0)
Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 2
Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.
Measured: Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 3
Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.
Measured: Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Genotypically Stable
A nasal wash specimen was collected at screening and on Days 7 (7-10), 12 (12-18), and 28 (28-34) post each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose to assess vaccine virus replication. Genotypic stability of recovered vaccine-type virus at the 15 mutations of phenotypic importance was assessed.
Measured: Day 0 after Dose 1 to 180 days after the final dose
Number of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Phenotypically Stable
A nasal wash specimen was collected at screening and on Days 7 (7-10), 12 (12-18), and 28 (28-34) post each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose to assess vaccine virus replication. Determination of the temperature sensitivity of recovered vaccine-type virus.
Measured: Day 0 after Dose 1 to 180 days after the final dose
Geometric Mean Titers (GMTs) of Serum HAI Antibodies to HPIV3 at Baseline
Pre-dose GMT of HAI antibody to HPIV3
Measured: Baseline (Day 0 prior to Dose 1)
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 1
Post-Dose 1 GMT of HAI antibody to HPIV3
Measured: Day 28-34 after Dose 1 (Dose 1 was on Day 0)
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 2
Post-Dose 2 GMT of HAI antibody to HPIV3
Measured: Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 3
Post-Dose 3 GMT of HAI antibody to HPIV3
Measured: Day 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 posted30 Jul 2007 (estimated)
- Study startOct 2007
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: The study was closed prior to enrollment of Cohort 2 due to a non-safety related sponsor decision.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Judith Falloon, MD, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508651
- Sponsor's protocol ID
- MI-CP150
- Status last verified
- Nov 2011
- First submitted
- 27 Jul 2007
- Last updated
- 30 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bernstein DI, Falloon J, Yi T. A randomized, double-blind, placebo-controlled, phase 1/2a study of the safety and immunogenicity of a live, attenuated human parainfluenza virus type 3 vaccine in healthy infants. Vaccine. 2011 Sep 16;29(40):7042-8. doi: 10.1016/j.vaccine.2011.07.031. Epub 2011 Jul 22.
PubMed 21782874
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Phase1/2a Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, and Viral Shedding of MEDI-560, A Live, Attenuated Recombinant Parainfluenza Virus Type 3 (PIV3) Vaccine, Administered Intranasally to Healthy Infants 1 to <12 Mos. of Age
- ClinicalTrials.gov ID
- NCT00508651
- Acronym / sponsor ID
- MI-CP150
- Conditions
- Healthy
- Keywords
- parainfluenza virus, children, vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was closed prior to enrollment of Cohort 2 due to a non-safety related sponsor decision.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 30 Jul 2007 (estimated)
- Results
- Posted 30 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to describe the safety and tolerability of 3 doses of MEDI-560 at 10^5 TCID50 when administered to children 6 to < 12 months of age who are HPIV3 (human parainfluenza virus type 3) seronegative at baseline and to infants 1 to < 3 months of age regardless of baseline serostatus.
Detailed description
This is a randomized, double-blind, placebo-controlled, multidose Phase 1/2a multicenter study designed to evaluate the safety, tolerability, viral shedding, immunogenicity, and genotypic and phenotypic stability of MEDI-560 in infants 1 to < 12 months of age. Three doses of MEDI-560 at a dosage level of 10^5 TCID50 were administered 0, 2, and 4 months after enrollment to a 30-participant cohort of 6 to < 12 month-old HPIV3 seronegative children randomized 2:1 to MEDI-560 vs placebo. A second 160-participant cohort of 1 to < 3 month-old infants not screened for baseline serostatus was planned but was not opened to enrollment for reasons other than safety. Participants were followed for safety through 180 days post last dose. Nasal wash specimens were collected at screening and Days 7, 12, and 28 following each dose and during unscheduled illness visits to assess vaccine virus shedding and genotypic and phenotypic stability of any shed vaccine virus. Blood was collected at screening to determine eligibility and prior to Dose 1 for baseline serostatus. Blood for assessment of antibodies to HPIV3 was collected approximately 7 to 12 days after Dose 1 and Dose 3 and 1 month after each dose for antibodies to PIV3.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 MEDI-560 | Experimental | Biological: MEDI-560MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson^TM Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI-560 in a sucrose phosphate glutamate buffer. |
| Cohort 1 Placebo | Placebo comparator | Biological: PlaceboPlacebo was a frozen preparation filled into Becton Dickinson^TM Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. |
Who may qualify
- Ages
- 1 month to 11 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 cohorts:
- Cohort 1: 6 to < 12 months (≥ 6 months of age and not yet reached their 1st year birthday); Cohort 2: 1 to < 3 months (> 28 days of age and not yet reached their 3rd month birthday)
- Cohort 1 only: Participant is seronegative to HPIV3 at screening as determined by ELISA; or the legal representative is willing to provide access to data documenting that the participant was screened for another MedImmune trial after written informed consent was obtained, and that the participant is seronegative to HPIV3 within 21 days prior to randomization into MI-CP150 as determined by ELISA at MedImmune
- Participant was the product of a normal full term pregnancy, defined as 36-42 weeks gestation
- Participant is in general good health
Key exclusion criteria (22 listed)
- Any fever (≥ 100.4°F [≥ 38.0°C], 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 prevent intranasal delivery of investigational product
- Cohort 1 only: weight < the fifth percentile for age on the day of randomization
- Cohort 2 only: history of low birth-weight (ie, < 2,500 grams at birth) or weight < fifth percentile for age on the day 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 investigational product dosing, except that infrequent use of over-the-counter medications such as pain relievers are 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-560MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson^TM luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI-560 in a sucrose phosphate glutamate buffer. | Biological | Cohort 1 MEDI-560 |
| PlaceboPlacebo was a frozen preparation filled into Becton Dickinson^TM luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer. | Biological | Cohort 1 Placebo |
Primary outcome
Number of Participants With Solicited Adverse Events (SEs) After Dose 1
Time frame: Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Number of Participants With SEs After Dose 2
Time frame: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants With SEs After Dose 3
Time frame: 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
Time frame: Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.
Number of Participants With AEs After Dose 2
Time frame: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.
Number of Participants With AEs After Dose 3
Time frame: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.
Number of Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1
Time frame: Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Number of Participants With MA-LRIs After Dose 2
Time frame: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants With MA-LRIs After Dose 3
Time frame: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of Participants With Serious Adverse Events (SAEs) After Dose 1
Time frame: Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Number of Participants With SAEs After Dose 2
Time frame: Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
One participant had event of pneumonia after Dose 2.
Number of Participants With SAEs After Dose 3
Time frame: Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of Participants With Significant New Medical Conditions (SNMCs)
Time frame: Day 0 through 180 days after final dose
A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.
22 secondary outcomes
Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation
Time frame: Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose.
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of Participants With Hemagglutination Inhibition (HAI) Seroconversion/Seroresponse to HPIV3 28 Days After Dose 1
Time frame: Days 28-34 after Dose 1 (Dose 1 was on Day 0)
Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 2
Time frame: Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 3
Time frame: Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Number of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Genotypically Stable
Time frame: Day 0 after Dose 1 to 180 days after the final dose
Number of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Phenotypically Stable
Time frame: Day 0 after Dose 1 to 180 days after the final dose
Geometric Mean Titers (GMTs) of Serum HAI Antibodies to HPIV3 at Baseline
Time frame: Baseline (Day 0 prior to Dose 1)
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 1
Time frame: Day 28-34 after Dose 1 (Dose 1 was on Day 0)
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 2
Time frame: Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 3
Time frame: Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21782874Bernstein DI, Falloon J, Yi T. A randomized, double-blind, placebo-controlled, phase 1/2a study of the safety and immunogenicity of a live, attenuated human parainfluenza virus type 3 vaccine in healthy infants. Vaccine. 2011 Sep 16;29(40):7042-8. doi: 10.1016/j.vaccine.2011.07.031. Epub 2011 Jul 22.
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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.
Judith Falloon, MD study director
MedImmune LLC
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MEDI-560 in people with Healthy, run by MedImmune LLC at 23 sites in United States.
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: stopped early, as of the sponsor's last update on 30 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. 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 30 Dec 2011). 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 Adverse Events (SEs) After Dose 1 (time frame: Days 0-28 after Dose 1 (Dose 1 was on Day 0)). The study lists 13 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 NCT00508651, 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 30 Dec 2011.