TerminatedPhase 1/2

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

Stopped: The study was closed prior to enrollment of Cohort 2 due to a non-safety related sponsor decision.

United States30 participantsStarted 2007-10

Plain-language 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.

Who can participate

Age range1 Month – 11 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female whose age on the day of randomization falls within one of the two age cohorts:
✓. 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

Exclusion criteria

What they're measuring

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

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

Number of Participants With SEs After Dose 2

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

Number of Participants With SEs After Dose 3

Timeframe: 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

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

Number of Participants With AEs After Dose 2

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

Number of Participants With AEs After Dose 3

Timeframe: 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

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

Trial details

NCT IDNCT00508651

SponsorMedImmune LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-04

Results submitted2011-09-08

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range1 Month – 11 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female whose age on the day of randomization falls within one of the two age cohorts:
✓. 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

Exclusion criteria

What they're measuring

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

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

Number of Participants With SEs After Dose 2

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

Number of Participants With SEs After Dose 3

Timeframe: 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

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

Number of Participants With AEs After Dose 2

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

Number of Participants With AEs After Dose 3

Timeframe: 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

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