NCT00686075

A Phase 1/2a, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-old Children and in 2 Month-old Infants

Completed Phase 1/Phase 2 Results posted Last updated 22 September 2014

What this trial tests

Phase 1/Phase 2 trial testing MEDI-534, Cohort 1 in Healthy in 1,338 participants. Completed in 1 August 2012.

Timeline

1 June 2008

Primary endpoint
1 August 2012

1 August 2012

Quick facts

Lead sponsor	MedImmune LLC
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1,338
Start date	1 June 2008
Primary completion	1 August 2012
Estimated completion	1 August 2012
Sites	100 locations across United States, Australia, Brazil, Canada, Finland, Germany, Israel, South Africa

Drugs / interventions tested

• MEDI-534, Cohort 1 — full drug profile →
• Placebo, Cohort 1
• MEDI-534, Cohort 2
• Placebo, Cohort 2
• MEDI-534, Cohort 3
• Placebo, Cohort 3
• MEDI-534, Cohort 4
• Placebo, Cohort 4
• MEDI-534, Cohort 5
• Placebo, Cohort 5

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

MedImmune LLC — full company profile →

Who can join

Adults 2 Months to 23 Months, any sex, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants With Solicited Symptoms After Dose 1
  Time frame: Within 28 days after Dose 1
  Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever greater than or equal to (\>=) 100.4 degrees Fahrenheit (F), runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngit
• Number of Participants With Solicited Symptoms After Dose 2
  Time frame: Within 28 days after Dose 2
  Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever \>=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
• Number of Participants With Solicited Symptoms After Dose 3
  Time frame: Within 28 days after Dose 3
  Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever \>=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 1
  Time frame: Within 28 days after Dose 1
  An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAEs) for Dose 1 are events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsoli
• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 2
  Time frame: Within 28 days after Dose 2
  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 2 are events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spo
• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 3
  Time frame: Within 28 days after Dose 3
  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 3 are events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spo

Sponsor's own description

Primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 in children 6 to less than (\<) 24 months of age and in infants 2 months of age.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.