Study of Quadrivalent Influenza Vaccine Among Adults

Influenza Clinical Trial

Official title:

Safety and Immunogenicity Trial Among Adults Administered Quadrivalent Influenza Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01218646
• Other study ID #: QIV03
• Secondary ID: UTN: U1111-1113-
• Status: Completed
• Phase: Phase 3
• First received: October 8, 2010
• Last updated: September 13, 2013
• Start date: October 2010
• Est. completion date: April 2011

Study information

• Verified date: September 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 739
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative
0.5 mL, Intramuscular
• Investigational Trivalent Inactivated Influenza Vaccine, No Preservative
0.5 mL, Intramuscular
• Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative
0.5 mL, Intramuscular
• Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	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.	Day 21 post-vaccination	No
Other	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.	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.	Day 21 post-vaccination	No
Other	Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older.	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)	Day 21 post-vaccination	No
Other	Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older	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.	Day 21 post-vaccination	No
Other	Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines.	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.	Day 0 up to day 21 post-vaccination	No
Primary	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.	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.	Day 21 post-vaccination	No
Primary	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.	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.	Day 21 post-vaccination	No
Primary	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	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.	Day 0 and Day 21 post-vaccination	No

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