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Safety and Reactogenicity of a PAL Combined With Seasonal Flu Vaccine in Healthy Adults

NCT02188810 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2016-02-12

No results posted yet for this study

Summary

This is a phase 1, research study is looking at the safety and acceptability of a new vaccine adjuvant (immune booster) called PAL when combined with the seasonal flu vaccine (Fluviral) to test the safety and effectiveness of new vaccines and medications on healthy volunteers.

The study will enroll approximately 48 healthy adult participants, and occur over 3 years. In the first six months/180 days of the study participants will have visits to the study site during which safety and immunogenicity outcomes will be measured. From Day 181 to Year 3, participants will be contacted by telephone or email to collect information on any adverse events.

Conditions

Interventions

BIOLOGICAL

PAL

Single dose administered intramuscularly.

BIOLOGICAL

TIV

Single dose administered intramuscularly .

Sponsors & Collaborators

  • Folia Biotech Inc.

    lead INDUSTRY

Principal Investigators

  • Joanne Langley, M.D. · Canadian Center for Vaccinology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02188810 on ClinicalTrials.gov