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NCT00953524 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.

Completed
Registry status
Phase 2
Development phase
849
Enrollment target

NCT00953524 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 849 participants.

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The verdict

NCT00953524, a Phase 2 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.

COMPLETED
Registry status
Phase 2
Development phase
849 participants
Enrollment target

Study Summary

The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine. Primary Objectives: * To describe the immunogenicity of the candidate vaccines after each injection. * To describe the safety of the candidate vaccines after each injection.

Interventions

  • BIOLOGICAL Normal saline solution (placebo)
  • BIOLOGICAL Monovalent Subvirion A/H1N1 Influenza vaccine (7.5 µg of HA)
  • BIOLOGICAL Monovalent Subvirion A/H1N1 Influenza vaccine (15 µg of HA)
  • BIOLOGICAL Monovalent Subvirion A/H1N1 Influenza vaccine (30 µg of HA)

Trial Details

FieldValue
Enrollment Target 849 participants
Start Date 2009-08
Est. Completion 2010-12
Phase Phase 2

Sponsor

Sanofi Pasteur, a Sanofi Company

153 total trials

What the Registry Record Tells You About NCT00953524

The ClinicalTrials.gov registry entry for NCT00953524 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 849 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Normal saline solution (placebo) is the first listed.

NCT00953524 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00953524 about?

NCT00953524 is a clinical study titled "A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly". The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine. Primary Objectives: * To describe the immunogenicity of the candidate vaccines after each injection. * To describe the safety of the candidate vaccines after each injection.

What is the current status of trial NCT00953524?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 849 participants. The study started on 2009-08. Estimated completion is 2010-12.

What interventions are being tested in trial NCT00953524?

The interventions under investigation include: Normal saline solution (placebo) (BIOLOGICAL), Monovalent Subvirion A/H1N1 Influenza vaccine (7.5 µg of HA) (BIOLOGICAL), Monovalent Subvirion A/H1N1 Influenza vaccine (15 µg of HA) (BIOLOGICAL), Monovalent Subvirion A/H1N1 Influenza vaccine (30 µg of HA) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00953524?

This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.