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FLU-VACS Comparative Study in Adults

NCT00133523 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2349

Last updated 2014-12-05

No results posted yet for this study

Summary

The purpose of this study is to compare 2 licensed flu vaccines to each other and to placebo (inactive substance). The study will be conducted among healthy adult participants aged 18-49 years and is expected to last 3 years. During year 1, participants will be assigned to receive 1 of the 2 licensed flu vaccines or placebo, given as either nasal spray (live-attenuated vaccine or placebo) or injection (inactivated vaccine or placebo). Participants will receive the same assigned vaccine or placebo during year 2. During year 3, participants will be followed, but will not receive flu vaccine. Each year blood samples will be collected before and 1 month after each vaccination and at the end of each flu season in order to measure how the body responds to the vaccine and how well participants were protected from the flu. During the flu season, participants with flu-like illness will provide information on symptoms and provide a throat swab to test for virus identification.

Conditions

Interventions

BIOLOGICAL

Cold-adapted live attenuated influenza virus vaccine, trivalent

Live-attenuated influenza vaccine; single annual dose administered as an intranasal spray.

OTHER

Placebo

Physiological saline administered as an intramuscular injection.

BIOLOGICAL

Trivalent inactivated influenza vaccine

Inactivated influenza vaccine; single annual dose administered as an intramuscular injection..

BIOLOGICAL

Trivalent inactivated influenza vaccine

Inactivated influenza vaccine; single annual dose administered as an intramuscular injection.

OTHER

Placebo

Normal allantoic fluid administered annually as an internasal spray.

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
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2007-07-31
Completion
2007-07-31

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 NCT00133523 on ClinicalTrials.gov