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A Phase 1/2A Study to Evaluate the Safety, Immunogenicity, and Shedding of MEDI-560 in Infants 1 to < 12 Months of Age

Primary Purpose

Healthy

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MEDI-560
Placebo
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy focused on measuring parainfluenza virus, children, vaccine

Eligibility Criteria

1 Month - 11 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 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)

  2. 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
  3. Participant was the product of a normal full term pregnancy, defined as 36-42 weeks gestation
  4. Participant is in general good health
  5. Participant's legal representative is available by telephone
  6. Written informed consent and Health Insurance Portability and Accountability Act authorization (if applicable) obtained from the participant's legal representative
  7. Participant's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator
  8. Participant is available to complete the follow-up period of 180 days after the final dose of investigational product as required by the protocol
  9. 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

Exclusion Criteria:

  1. Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or lower respiratory illness within 7 days prior to randomization
  2. Moderate or severe nasal congestion that in the investigator's opinion could prevent intranasal delivery of investigational product
  3. Cohort 1 only: weight < the fifth percentile for age on the day of randomization
  4. 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
  5. 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
  6. 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
  7. History of receipt of blood transfusion or expected receipt through 30 days after final investigational product dosing
  8. History of receipt of immunoglobulin products or expected receipt through 30 days after final investigational product dosing
  9. Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 30 days after final investigational product dosing
  10. 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
  11. 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
  12. Known or suspected immunodeficiency, including human immunodeficiency virus
  13. 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)
  14. Contact with pregnant caregiver within 28 days after each dose
  15. 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
  16. 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
  17. History of allergic reaction to any component of the investigational product
  18. 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
  19. Known or suspected active or chronic hepatitis infection
  20. 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
  21. A family member or a household contact who is an employee of the research center or otherwise involved with the conduct of the study
  22. Any condition that, in the opinion of the investigator, might interfere with investigational product evaluation

Sites / Locations

  • Children's Investigational Research Program
  • Arkansas Pediatric Clinic
  • Madera Family Medical Group
  • Allergy Medical Group of the North Area
  • Miami Children's Hospital
  • Homestead Clinical Research
  • University of South Florida College of Medicine Department of Pediatrics
  • Kapiolani Medical Center for Women and Children
  • Michael W. Simon, M.D.
  • Tulane University
  • Tufts-New England Medical Center
  • Meridian Clinical Research LLC
  • Children's Lung Specialists Ltd.
  • SUNY Upstate Medical University
  • Duke Health Center- Pickett Road
  • Cincinnati Children's Hospital Medical Center
  • University Hospitals Case Medical Center
  • Oklahoma State University Center for Health Sciences
  • St. Luke's Hospital
  • Belleview Pediactric Assoc.
  • Holston Medical Group
  • Dixie Pediatrics
  • University Physicians Internal Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cohort 1 MEDI-560

Cohort 1 Placebo

Arm Description

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.

Placebo was a frozen preparation filled into Becton Dickinson^TM Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.

Outcomes

Primary Outcome Measures

Number of Participants With Solicited Adverse Events (SEs) After Dose 1
Number of Participants With SEs After Dose 2
Number of Participants With SEs After Dose 3
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.
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.
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.
Number of Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1
Number of Participants With MA-LRIs After Dose 2
Number of Participants With MA-LRIs After Dose 3
Number of Participants With Serious Adverse Events (SAEs) After Dose 1
Number of Participants With SAEs After Dose 2
One participant had event of pneumonia after Dose 2.
Number of Participants With SAEs After Dose 3
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.

Secondary Outcome Measures

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.
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.
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.
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.
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Geometric Mean Titers (GMTs) of Serum HAI Antibodies to HPIV3 at Baseline
Pre-dose GMT of HAI antibody to HPIV3
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 1
Post-Dose 1 GMT of HAI antibody to HPIV3
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 2
Post-Dose 2 GMT of HAI antibody to HPIV3
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 3
Post-Dose 3 GMT of HAI antibody to HPIV3

Full Information

First Posted
July 27, 2007
Last Updated
November 28, 2011
Sponsor
MedImmune LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00508651
Brief Title
A Phase 1/2A Study to Evaluate the Safety, Immunogenicity, and Shedding of MEDI-560 in Infants 1 to < 12 Months of Age
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Terminated
Why Stopped
The study was closed prior to enrollment of Cohort 2 due to a non-safety related sponsor decision.
Study Start Date
October 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MedImmune LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
parainfluenza virus, children, vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 MEDI-560
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 1 Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo was a frozen preparation filled into Becton Dickinson^TM Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
Intervention Type
Biological
Intervention Name(s)
MEDI-560
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo was a frozen preparation filled into Becton Dickinson^TM luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
Primary Outcome Measure Information:
Title
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)
Title
Number of Participants With SEs After Dose 2
Time Frame
Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Title
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)
Title
Number of Participants With Adverse Events (AEs) After Dose 1
Description
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.
Time Frame
Days 0-28 after Dose 1 (Dose 1 was on Day 0)
Title
Number of Participants With AEs After Dose 2
Description
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.
Time Frame
Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Title
Number of Participants With AEs After Dose 3
Description
Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.
Time Frame
Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Title
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)
Title
Number of Participants With MA-LRIs After Dose 2
Time Frame
Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Title
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)
Title
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)
Title
Number of Participants With SAEs After Dose 2
Description
One participant had event of pneumonia after Dose 2.
Time Frame
Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)
Title
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)
Title
Number of Participants With Significant New Medical Conditions (SNMCs)
Description
A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.
Time Frame
Day 0 through 180 days after final dose
Secondary Outcome Measure Information:
Title
Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation
Description
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
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.
Title
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1
Description
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time Frame
Days 7-10 after Dose 1 (Dose 1 was on Day 0)
Title
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1
Description
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time Frame
Days 12-18 after Dose 1 (Dose 1 was on Day 0)
Title
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1
Description
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time Frame
Days 28-34 after Dose 1 (Dose 1 was on Day 0)
Title
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)
Title
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2
Description
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time Frame
Days 7-10 after Dose 2 (Dose 2 was on Day 48-64)
Title
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2
Description
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time Frame
Days 12-18 after Dose 2 (Dose 2 was on Day 48-64)
Title
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2
Description
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time Frame
Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Title
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2
Description
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time Frame
Days 0-34 after Dose 2 (Dose 2 was on Day 48-64)
Title
Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3
Description
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time Frame
Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Title
Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3
Description
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time Frame
Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Title
Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3
Description
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time Frame
Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Title
Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3.
Description
Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.
Time Frame
Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Title
Number of Participants With Hemagglutination Inhibition (HAI) Seroconversion/Seroresponse to HPIV3 28 Days After Dose 1
Description
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.
Time Frame
Days 28-34 after Dose 1 (Dose 1 was on Day 0)
Title
Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 2
Description
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.
Time Frame
Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Title
Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 3
Description
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.
Time Frame
Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)
Title
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
Description
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.
Time Frame
Day 0 after Dose 1 to 180 days after the final dose
Title
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
Description
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.
Time Frame
Day 0 after Dose 1 to 180 days after the final dose
Title
Geometric Mean Titers (GMTs) of Serum HAI Antibodies to HPIV3 at Baseline
Description
Pre-dose GMT of HAI antibody to HPIV3
Time Frame
Baseline (Day 0 prior to Dose 1)
Title
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 1
Description
Post-Dose 1 GMT of HAI antibody to HPIV3
Time Frame
Day 28-34 after Dose 1 (Dose 1 was on Day 0)
Title
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 2
Description
Post-Dose 2 GMT of HAI antibody to HPIV3
Time Frame
Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)
Title
Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 3
Description
Post-Dose 3 GMT of HAI antibody to HPIV3
Time Frame
Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
11 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Falloon, MD
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
Children's Investigational Research Program
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Facility Name
Arkansas Pediatric Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Madera Family Medical Group
City
Madera
State/Province
California
ZIP/Postal Code
93637
Country
United States
Facility Name
Allergy Medical Group of the North Area
City
Roseville
State/Province
California
ZIP/Postal Code
95678
Country
United States
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Homestead Clinical Research
City
Naranja
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Facility Name
University of South Florida College of Medicine Department of Pediatrics
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826-1032
Country
United States
Facility Name
Michael W. Simon, M.D.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tufts-New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Meridian Clinical Research LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Children's Lung Specialists Ltd.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89107
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke Health Center- Pickett Road
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Oklahoma State University Center for Health Sciences
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74127
Country
United States
Facility Name
St. Luke's Hospital
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Belleview Pediactric Assoc.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15202
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Dixie Pediatrics
City
St. George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
University Physicians Internal Medicine
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21782874
Citation
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.
Results Reference
result

Learn more about this trial

A Phase 1/2A Study to Evaluate the Safety, Immunogenicity, and Shedding of MEDI-560 in Infants 1 to < 12 Months of Age

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