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Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2012-2013, in Non-Elderly Adult and Elderly Subjects

NCT01752881 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2012-12-19

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 three weeks 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

Influenza vaccine (split virion, inactivated)

AdimFlu-S, Inactivated Influenza Vaccine Trivalent Types A and B (Split) Formulation 2012-2013 Dosage: 0.5mL/per syringe Administration route: Intramuscular Injection, once

BIOLOGICAL

AdimFlu-S

Sponsors & Collaborators

  • Adimmune Corporation

    lead INDUSTRY

Principal Investigators

  • Chih-Jen Chang, MD · National Cheng-Kung University Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2012-08-31
Completion
2012-09-30

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 NCT01752881 on ClinicalTrials.gov