NCT00508651

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 1 Month – 11 Months
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	MEDI-560	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	Placebo	Placebo was a frozen preparation filled into Becton Dickinson\^TM luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2007-07-30
• Last updated: 2011-12-30
• Results posted: 2011-12-30

Locations

23 sites across 1 country: United States