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Th1 Response to Influenza: Aging and Vaccine Efficacy

NCT00396305 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2010-08-27

No results posted yet for this study

Summary

This research study is being done because influenza (flu) affects many people each year throughout the world. The elderly and those with chronic health problems are at greater risk for complications from the flu. The purpose of this research study is to evaluate vaccination strategies in the elderly and others receiving the influenza vaccination in order to increase protection. All subjects will receive the flu vaccine as an injection in the muscle of the upper arm. Participants may receive a booster \[an extra dose of vaccine or placebo (inactive substance)\] shot. Study participants will include healthy adult volunteers, ages 21-40, 60-89, or 90 years and older. Subjects will be involved in study related procedures for 6 months.

Conditions

Interventions

DRUG

Placebo

Sterile phosphate buffered saline solution.

BIOLOGICAL

Trivalent Inactivated Influenza

The trivalent influenza vaccine is a sterile suspension prepared from the allantoic fluids of chicken embryos infected with a specific type of influenza virus. Each 0.5 mL dose of the vaccine contains 15 mcg hemagglutinin (HA) of 3 strains of virus (H1N1, H3N2, and B). The vaccine is a liquid preparation; as such, no diluent is required. It is essentially clear and slightly opalescent in color.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2007-09-30
Completion
2008-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00396305 on ClinicalTrials.gov