A Study of the Immunogenicity of Swine-origin A/H1N1 Influenza Vaccine in Healthy Adults

January 10, 2014 updated by: Sanofi Pasteur, a Sanofi Company

Immunogenicity of the Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine Without Adjuvant in Healthy Adult Subjects

This study is designed to describe the immunogenicity of a pandemic A/H1N1 influenza vaccine in healthy adults given a lower vaccine dose and in a similar group given a full dose of the vaccine.

The primary objective is to describe describe the immune response of the inactivated, split-virion swine-origin A/H1N1 influenza vaccine without adjuvant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All participants will receive a single dose of study vaccine and will also be monitored for serious adverse events and adverse events of special interest occurring from Days 0 to 21 and at 6 months post-vaccination.

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Phase 2

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

  • France
      • Rennes, France, 35000
      • Rueil Malmaison, France, 92502

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

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria :

  • Aged 18 to 60 years on the day of inclusion
  • Informed consent form has been signed and dated
  • Able to attend all scheduled visits and to comply with all trial procedures
  • For a woman of childbearing potential, use of an effective method of contraception from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination
  • Entitled to national social security

Exclusion Criteria :

  • Known pregnancy, or a positive urine pregnancy test
  • Currently breastfeeding a child
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination
  • Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • Self-reported seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
  • Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
  • Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator
  • Participant previously vaccinated with an A/H1N1 pandemic influenza vaccine during vaccination campaign or in a clinical trial
  • Personal history of influenza infection since May 2009
  • Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group 1
Swine-origin A/H1N1 Vaccine Low-dose
Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)
0.3 mL, Intramuscular (IM)
Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)
0.5 mL, Intramuscular (IM)
Experimental: Study Group 2
Swine-origin A/H1N1 Vaccine High-dose
Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)
0.3 mL, Intramuscular (IM)
Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)
0.5 mL, Intramuscular (IM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To provide information concerning the immunogenicity in terms of anti-hemagglutinin (HA) antibody titers against non-adjuvanted pandemic A/H1N1 influenza vaccine.
Time Frame: 21 days post-vaccination
21 days post-vaccination

Collaborators and Investigators

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

Sponsor

Sanofi Pasteur, a Sanofi Company

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

March 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 17, 2010

First Submitted That Met QC Criteria

March 17, 2010

First Posted (Estimate)

March 18, 2010

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPF18
  • 2010-018991-25 (EudraCT Number)
  • UTN: U1111-1112-8378 (Other Identifier: WHO)

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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