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A Study of Different Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly

NCT00952276 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 548

Last updated 2011-10-03

Study results available
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Summary

The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in adults and the elderly.

Primary Objectives:

* To describe the immunogenicity of the candidate vaccines after a single injection.
* To describe the safety of the candidate vaccines after a single injection.

Conditions

Interventions

BIOLOGICAL

Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant

0.5 mL, Intramuscular on Day 0

BIOLOGICAL

Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant

0.5 mL, Intramuscular on Day 0

BIOLOGICAL

Monovalent Subvirion A/H1N1 influenza vaccine

0.5 mL, Intramuscular on Day 0

BIOLOGICAL

Monovalent Subvirion A/H1N1 influenza vaccine

0.5 mL, Intramuscular on Day 0

BIOLOGICAL

Normal saline solution

0.5 mL, Intramuscular on Day 0

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-12-31
Completion
2011-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00952276 on ClinicalTrials.gov