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Immunogenicity and Safety of AdimFlu-S 2011-2012 in Non-Elderly Adult and Elderly Subjects

NCT01411358 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2012-07-12

No results posted yet for this study

Summary

The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HAI) at 21 days post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).

Conditions

Interventions

BIOLOGICAL

non-elderly aged between 18 and 60

one dose of 0.5mL AdimFlu-S

BIOLOGICAL

elderly aged over 60

one dose of 0.5mL AdimFlu-S

Sponsors & Collaborators

  • Adimmune Corporation

    lead INDUSTRY

Principal Investigators

  • Gin-Hsiang Wu, MD · National Cheng-Kung University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Taiwan

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 NCT01411358 on ClinicalTrials.gov