Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine

April 16, 2012 updated by: Sanofi

Safety and Immunogenicity of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine in Healthy Adults

Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity using adjuvants were initiated. The present study is part of this endeavor. It is primarily a formulation/dose-finding study with a secondary aim at generating safety and immunogenicity data for the final formulation for the development of a pre-pandemic vaccine.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase I, observer-blinded, randomized, controlled multicenter, dose-finding study in adult subjects. All vaccines will be administered as a two-dose schedule in (H5N1) immunologically-naïve adults. Immunogenicity and safety will be evaluated after each injection.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
375

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
    • Florida
      • South Miami, Florida, United States, 33143
    • Missouri
      • Springfield, Missouri, United States, 65802
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cincinnati, Ohio, United States, 45227
    • Tennessee
      • Knoxville, Tennessee, United States, 37920

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria :

  • Healthy adult aged 18 to 40 years on the day of inclusion.
  • Provides signed informed consent prior to study procedures.
  • Able to attend all scheduled visits and comply with all trial procedures.
  • For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to the first vaccination, until at least 4 weeks after last vaccination.

Exclusion Criteria :

  • Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the standard-dose Fluzone® vaccine or to a vaccine containing any of the same substances
  • For a woman of child-bearing potential, known pregnancy or positive serum/urine pregnancy test
  • Breast feeding woman
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the (first) trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, oral, parenteral, or inhaled steroids
  • Has an acute or chronic medical illness or any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or would interfere with the evaluation of responses or render the subject unable to meet the requirements of the protocol
  • Known or suspected current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
  • History of receipt of blood or immunoglobulin or other blood-derived products within the 3 months prior to enrollment in this study that might interfere with the assessment of immune response
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
  • Planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination
  • Known Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or Hepatitis C seropositivity
  • Personal or family history of Guillain-Barré Syndrome
  • Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
  • Active neoplastic disease or a history of any hematologic malignancy
  • Previous participation in a pandemic flu trial
  • History of H5N1 infection or exposure to presumed/confirmed H5N1 human/animal cases
  • Known seizure/epilepsy history and/or taking anti-seizure medication
  • Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to enroll in the study.
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 1
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 2
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 3
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 4
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 5
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 6
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 1
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 2
Experimental: 2
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 1
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 2
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 3
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 4
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 5
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 6
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 1
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 2
Experimental: 3
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 1
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 2
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 3
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 4
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 5
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 6
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 1
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 2
Experimental: 4
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 1
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 2
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 3
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 4
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 5
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 6
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 1
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 2
Experimental: 5
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 1
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 2
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 3
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 4
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 5
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 6
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 1
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 2
Experimental: 6
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 1
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 2
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 3
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 4
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 5
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 6
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 1
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 2
Active Comparator: 7
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 1
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 2
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 3
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 4
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 5
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 6
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 1
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 2
Active Comparator: 8
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 1
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 2
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 3
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 4
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 5
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 6
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 1
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 2
Placebo Comparator: 9
Biological: Physiological saline
0.5 mL, IM, 2 injections

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
To provide information concerning the safety after primary administration of A/H1N1 vaccine
Time Frame: 6 months post-vaccination
6 months post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FUF04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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