MedTrace Logo

Eldery High Dose TIV 2005

NCT00115531 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 414

Last updated 2014-12-19

No results posted yet for this study

Summary

The purpose of this study is to compare a new higher-dose influenza virus vaccine to the standard dose vaccine in elderly adults who can walk. Current influenza vaccines protect elderly against viral influenza but not as well as desired. It is expected that the higher doses vaccine can be given with little reaction, but this needs to be tested. Up to 410 people ages 65 years and older will be recruited from the community and from existing volunteer populations. Participants will receive either the high or standard dose injected in the muscle, remain in the clinic for 20 minutes afterward, and maintain a daily memory aid for 7 days. The memory aid will be reviewed by telephone 8-12 days after the injection and return to the clinic or contacted by telephone 6 months after the injection.

Conditions

Interventions

BIOLOGICAL

Trivalent inactivated influenza vaccine

Standard Dose Influenza Vaccine Fluzone® (15 µg HA / viral strain; 45 µg/0.5 mL dose) will be administered to Arm 1: 200 subjects intramuscularly on day 0.

BIOLOGICAL

Trivalent inactivated influenza vaccine

High Dose Influenza Fluzone® Vaccine (60 µg HA / viral strain; 180 µg/0.5 mL dose) will be administered to Arm 2: 200 subjects intramuscularly on Day 0.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-04-30
Completion
2005-11-30

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 NCT00115531 on ClinicalTrials.gov