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A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age

NCT01258595 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2016-05-16

Study results available
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Summary

The aim of the study is to generate data on key parameters associated with assessment of influenza vaccines in individuals 50-64 years of age

Primary Objective:

* To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine (TIV) compared to TIV.
* To describe the safety profile of High-Dose Trivalent Inactivated Influenza Vaccine, as assessed by solicited adverse reactions collected for 7 days post-vaccination, and unsolicited adverse events (including Serious Adverse Events and Adverse Events of Special Interests) collected between Visit 1 and Visit 2

Conditions

Interventions

BIOLOGICAL

High-Dose Trivalent Inactivated Influenza Vaccine

0.5 mL Intramuscular

BIOLOGICAL

Trivalent Inactivated Influenza Vaccine

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-03-31
Completion
2011-04-30

Countries

  • United States

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 NCT01258595 on ClinicalTrials.gov