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
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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 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Group 1: Investigational Quadrivalent Influenza Vaccine
Participants will receive a dose of Investigational Quadrivalent Inactivated Influenza Vaccine
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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
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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
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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® |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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)
- 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.
- 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.

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

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
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 |
Study Director: | Medical Director | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi Pasteur, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT01218646 |
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 |
Influenza Quadrivalent Inactivated Influenza Vaccine Trivalent Inactivated Influenza Vaccine Influenza viruses |
Influenza, Human Respiratory Tract Infections Infections Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |