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Trial record 1 of 1 for:    QIV03
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Study of Quadrivalent Influenza Vaccine Among Adults

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ClinicalTrials.gov Identifier: NCT01218646
Recruitment Status : Completed
First Posted : October 11, 2010
Results First Posted : September 12, 2013
Last Update Posted : October 23, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain, and the investigational TIV containing the alternate B strain in adult subjects.

Primary Objective:

  • To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011 TIV (containing the primary B strain) and investigational TIV (containing the alternate B strain) as assessed by geometric mean titer (GMT) ratios for each of the four virus strains separately among subjects 65 years of age and older

Observational Objective:

  • To describe the safety profiles of TIV among subjects 18 years of age and older and QIV in subjects 65 years and older, as assessed by solicited injection site and systemic adverse events (AEs) collected for 7 days post-vaccination, unsolicited adverse events collected from 21 days post-vaccination, and adverse events of special interest and serious adverse events (SAEs) collected from Visit 1 to Visit 2.

Condition or disease Intervention/treatment Phase
Influenza Biological: Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative Biological: Investigational Trivalent Inactivated Influenza Vaccine, No Preservative Biological: Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative Phase 3

Detailed Description:
All participants will receive a single dose of their assigned vaccine during Visit 1. They will be followed up for safety and immunogenicity through Day 21 post-vaccination (Visit 2)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 739 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Trial Among Adults Administered Quadrivalent Influenza Vaccine
Study Start Date : October 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Group 1: Investigational Quadrivalent Influenza Vaccine
Participants will receive a dose of Investigational Quadrivalent Inactivated Influenza Vaccine
Biological: Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative
0.5 mL, Intramuscular

Experimental: Group 2: Investigational Trivalent Influenza Vaccine
Participants will receive a dose of Investigational Trivalent Inactivated Influenza Vaccine
Biological: Investigational Trivalent Inactivated Influenza Vaccine, No Preservative
0.5 mL, Intramuscular

Active Comparator: Group 3: Licensed 2010-2011 Trivalent Influenza Vaccine
Participants will receive a dose of Licensed 2010-2011 Trivalent Inactivated Influenza Vaccine
Biological: Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative
0.5 mL, Intramuscular
Other Name: Fluzone®

Active Comparator: Group 4: Licensed 2010-2011 Trivalent Influenza Vaccine
Participants will receive a dose of Licensed 2010-2011 Trivalent Inactivated Influenza Vaccine
Biological: Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative
0.5 mL, Intramuscular
Other Name: Fluzone®




Primary Outcome Measures :
  1. Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older. [ Time Frame: Day 21 post-vaccination ]
    Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

  2. Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. [ Time Frame: Day 21 post-vaccination ]
    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

  3. Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older [ Time Frame: Day 0 and Day 21 post-vaccination ]
    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.


Other Outcome Measures:
  1. Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines (TIV) With Corresponding B Strains in Participants Aged 65 Years and Older. [ Time Frame: Day 21 post-vaccination ]

    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as < 10.

    Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.


  2. Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. [ Time Frame: Day 21 post-vaccination ]

    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

    Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥ 1:10 and ≥ four-fold increase in post-vaccination titers.


  3. Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. [ Time Frame: Day 21 post-vaccination ]

    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

    Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 1:40 (l/dil)


  4. Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older [ Time Frame: Day 21 post-vaccination ]

    Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

    Seroconversion was defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.


  5. Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. [ Time Frame: Day 0 up to day 21 post-vaccination ]

    Solicited injection site reactions: Pain, Erythema and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.

    Grade 3 Injection site reactions: Pain - Significant; prevents daily activity; Erythema and Swelling >100 mm.

    Grade 3 solicited systemic reactions: Fever (Temperature) ≥102.1°F; Headache, Malaise, and Myalgia - Significant; prevents daily activity.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Subject is 18 years of age or older on the day of inclusion.
  • Informed consent form (ICF) 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 or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks post-vaccination.

Exclusion criteria:

  • Known pregnancy, or a positive urine pregnancy test.
  • Currently breastfeeding a child.
  • History of serious adverse reaction to any influenza vaccine.
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination.
  • Planned receipt of any vaccine between Visit 1 and Visit 2.
  • Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first study vaccination or during the course of the study.
  • Receipt of any influenza vaccine since 01 August 2010 (including 2009 H1N1 monovalent vaccine).
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances.
  • Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response.
  • Thrombocytopenia, bleeding disorder, or receipt of anticoagulants contraindicating intramuscular vaccination.
  • Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.
  • Personal history of Guillain-Barré Syndrome (GBS).
  • 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).
  • Any chronic illness that, in the opinion of the Investigator, is not well controlled or that may interfere with trial conduct or completion or with assessment of adverse events.
  • Known seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
  • Current alcohol or drug use that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.
  • Identified as employees 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 (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01218646


Locations
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United States, Alabama
Hoover, Alabama, United States, 35216
United States, Florida
South Miami, Florida, United States, 33143
United States, Missouri
Springfield, Missouri, United States, 65802
United States, New York
New York, New York, United States, 10004
Rochester, New York, United States, 14609
United States, Ohio
Cincinnati, Ohio, United States, 45249
United States, Pennsylvania
Allentown, Pennsylvania, United States, 18102
Bensalem, Pennsylvania, United States, 19020
United States, Rhode Island
Warwick, Rhode Island, United States, 02866
United States, South Carolina
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
Nashville, Tennessee, United States, 37212
United States, Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.

Additional Information:
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01218646     History of Changes
Other Study ID Numbers: QIV03
UTN: U1111-1113-3619 ( Other Identifier: WHO )
First Posted: October 11, 2010    Key Record Dates
Results First Posted: September 12, 2013
Last Update Posted: October 23, 2013
Last Verified: September 2013

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Influenza
Quadrivalent Inactivated Influenza Vaccine
Trivalent Inactivated Influenza Vaccine
Influenza viruses

Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs