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

NCT00508651 | Terminated Phase 1 Results

• 1 other identifier: MI-CP150
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 23

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.

Conditions

Healthy

Keywords

parainfluenza virus, children, vaccine

Outcome Measures

Primary Outcomes (13)

• Number of Participants With Solicited Adverse Events (SEs) After Dose 1

  Days 0-28 after Dose 1 (Dose 1 was on Day 0)

• Number of Participants With SEs After Dose 2

  Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)

• Number of Participants With SEs After Dose 3

  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.

  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.

  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.

  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

  Days 0-28 after Dose 1 (Dose 1 was on Day 0)

• Number of Participants With MA-LRIs After Dose 2

  Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)

• Number of Participants With MA-LRIs After Dose 3

  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

  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.

  Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)

• Number of Participants With SAEs After Dose 3

  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.

  Day 0 through 180 days after final dose

Secondary Outcomes (22)

• Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation

  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

  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

  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

  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

  Days 0-34 after Dose 1 (Dose 1 was on Day 0)

Study Arms (2)

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.

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.

Biological: Placebo

Interventions

MEDI-560 BIOLOGICAL

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.

Cohort 1 MEDI-560

Placebo BIOLOGICAL

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

Cohort 1 Placebo

Eligibility Criteria

• Age: 1 Month - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (23)

Children's Investigational Research Program

Bentonville, Arkansas, 72712, United States

Location

Arkansas Pediatric Clinic

Little Rock, Arkansas, 72205, United States

Location

Madera Family Medical Group

Madera, California, 93637, United States

Location

Allergy Medical Group of the North Area

Roseville, California, 95678, United States

Location

Miami Children's Hospital

Miami, Florida, 33155, United States

Location

Homestead Clinical Research

Naranja, Florida, 33032, United States

Location

University of South Florida College of Medicine Department of Pediatrics

Tampa, Florida, 33606, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826-1032, United States

Location

Michael W. Simon, M.D.

Lexington, Kentucky, 40503, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Tufts-New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Meridian Clinical Research LLC

Omaha, Nebraska, 68134, United States

Location

Children's Lung Specialists Ltd.

Las Vegas, Nevada, 89107, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Duke Health Center- Pickett Road

Durham, North Carolina, 27705, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Oklahoma State University Center for Health Sciences

Tulsa, Oklahoma, 74127, United States

Location

St. Luke's Hospital

Bethlehem, Pennsylvania, 18015, United States

Location

Belleview Pediactric Assoc.

Pittsburgh, Pennsylvania, 15202, United States

Location

Holston Medical Group

Kingsport, Tennessee, 37660, United States

Location

Dixie Pediatrics

St. George, Utah, 84790, United States

Location

University Physicians Internal Medicine

Huntington, West Virginia, 25701, United States

Location

Related Publications (1)

• 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.

  PMID: 21782874 RESULT

Limitations and Caveats

Cohort 2 was not enrolled due to a sponsor decision.

Results Point of Contact

• Title: Judith Falloon, MD
• Organization: MedImmune, LLC

falloonj@medimmune.com

301 398 0000

Study Officials

• Judith Falloon, MD

  MedImmune LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 27, 2007
• First Posted: July 30, 2007
• Study Start: October 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: December 30, 2011
• Results First Posted: December 30, 2011

Record last verified: 2011-11

Locations

US (23)