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Sanofi H1N1 + TIV - Adults and Elderly

NCT00943878 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 805

Last updated 2012-08-01

Study results available
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Summary

The purpose of this study is to assess the safety and immune response (body's defense against disease) to an experimental H1N1 influenza vaccine against the 2009 H1N1 virus. This study will help determine how the H1N1 flu shot should be given with the seasonal flu shot to make it most effective. Participants will include up to 850 healthy adults, ages 18 and older. Participants will receive 2 H1N1 vaccines in addition to placebo (inactive substance) and the seasonal flu shot over 3 study visits about 21 days apart. Study procedures include: medical history, physical exam, maintaining a memory aid, and blood sample collection. Participants will be involved in the study for about 8 months.

Conditions

Interventions

BIOLOGICAL

Trivalent inactivated influenza vaccine

Licensed trivalent influenza vaccine (TIV) administered as a single 0.5 mL intramuscular injection in the deltoid muscle.

BIOLOGICAL

Inactivated H1N1 Vaccine

Two doses of inactivated influenza H1N1 vaccine, 15 mcg per dose, administered as a single 0.5 milliliters (mL) intramuscular injection in the deltoid muscle.

DRUG

Placebo

Normal saline (placebo control) administered as a single 0.5 mL intramuscular injection in the deltoid muscle.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-04-30
Completion
2010-04-30

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 NCT00943878 on ClinicalTrials.gov