Study of Quadrivalent Influenza Vaccine Among Adults

NCT01218646 | Completed Phase 3 Results

• 2 other identifiers: QIV03UTN: U1111-1113-3619
• Study Type: interventional
• Target: 739
• Locations: 1 country
• Sites: 12

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.

Conditions

Influenza

Keywords

Influenza; Quadrivalent Inactivated Influenza Vaccine; Trivalent Inactivated Influenza Vaccine; Influenza viruses

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Other Outcomes (5)

• 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.

  Day 21 post-vaccination

• 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.

  Day 21 post-vaccination

• Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older.

  Day 21 post-vaccination

Study Arms (4)

Group 1: Investigational Quadrivalent Influenza Vaccine

EXPERIMENTAL

Participants will receive a dose of Investigational Quadrivalent Inactivated Influenza Vaccine

Biological: Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative

Group 2: Investigational Trivalent Influenza Vaccine

EXPERIMENTAL

Participants will receive a dose of Investigational Trivalent Inactivated Influenza Vaccine

Biological: Investigational Trivalent Inactivated Influenza Vaccine, No Preservative

Group 3: Licensed 2010-2011 Trivalent Influenza Vaccine

ACTIVE COMPARATOR

Participants will receive a dose of Licensed 2010-2011 Trivalent Inactivated Influenza Vaccine

Biological: Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative

Group 4: Licensed 2010-2011 Trivalent Influenza Vaccine

ACTIVE COMPARATOR

Participants will receive a dose of Licensed 2010-2011 Trivalent Inactivated Influenza Vaccine

Biological: Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative

Interventions

Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative BIOLOGICAL

0.5 mL, Intramuscular

Group 1: Investigational Quadrivalent Influenza Vaccine

Investigational Trivalent Inactivated Influenza Vaccine, No Preservative BIOLOGICAL

0.5 mL, Intramuscular

Group 2: Investigational Trivalent Influenza Vaccine

Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Fluzone®

Group 3: Licensed 2010-2011 Trivalent Influenza Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (12)

Unknown Facility

Hoover, Alabama, 35216, United States

Location

Unknown Facility

South Miami, Florida, 33143, United States

Location

Unknown Facility

Springfield, Missouri, 65802, United States

Location

Unknown Facility

New York, New York, 10004, United States

Location

Unknown Facility

Rochester, New York, 14609, United States

Location

Unknown Facility

Cincinnati, Ohio, 45249, United States

Location

Unknown Facility

Allentown, Pennsylvania, 18102, United States

Location

Unknown Facility

Bensalem, Pennsylvania, 19020, United States

Location

Unknown Facility

Warwick, Rhode Island, 02866, United States

Location

Unknown Facility

Mt. Pleasant, South Carolina, 29464, United States

Location

Unknown Facility

Nashville, Tennessee, 37212, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 11, 2010
• Study Start: October 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: April 1, 2011
• Last Updated: October 23, 2013
• Results First Posted: September 12, 2013

Record last verified: 2013-09

Locations

US (12)