Clinical trial NCT01240746: Study of Quadrivalent Influenza Vaccine Among Children
Official title: Safety and Immunogenicity Among Children Administered Quadrivalent Influenza Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Quadrivalent Influenza Vaccine
Trivalent Influenza Vaccine
Influenza viruses
Fluzone®
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-11-15
Enrollment: 4363
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 (B1), and the investigational TIV containing the alternate B (B2) strain in children.

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 children aged 6 months to less than 9 years of age

Secondary Objective:

To demonstrate superiority of antibody responses to each B strain in QIV compared with antibody titers following vaccination with the TIV that does not contain the corresponding B strain, as assessed by GMT ratios and seroconversion rates.

Observational Objective:

To describe the safety profile of QIV among subjects 6 months to less than 9 years of age, 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.

Detailed description: Participants will receive a single dose of their assigned vaccine during Visit 1. For those requiring two doses of influenza vaccine, as per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of the assigned vaccine will be administered at Visit 2. All participants will be followed up for safety (up to 6 months post final vaccination) and for immunogenicity up to Day 28 post-vaccination (Visit 2 or Visit 3, as appropriate).

Eligibility criteria: Inclusion Criteria:

* Subject is 6 months to \< 9 years of age on the day of inclusion.
* Parent/guardian is willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
* Subject is in reasonably good health as assessed by the Investigator.
* Informed consent is granted by the parent(s) or other legally acceptable representative; assent by subjects 7 to \< 9 years of age.
* For subjects 6 months to \< 24 months of age, born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg (5.5 lbs).

Exclusion Criteria:

* History of allergy to egg proteins or any constituents of the vaccine.
* History of serious adverse reaction to any influenza vaccine.
* Any vaccination scheduled between Visit 1 and Visit 2 (or Visit 1 and Visit 3 for those requiring two doses).
* Receipt of any vaccine in the 4 weeks preceding the first study vaccination.
* 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.
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, 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.
* 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).
* Personal or immediate family history of congenital immune deficiency.
* Personal developmental delay, neurologic disorder, or seizure disorder.
* Any chronic illness that, in the opinion of the Investigator, is not well controlled and may interfere with trial conduct or completion, or with assessment of adverse events.
* Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.
* Receipt of blood or blood-derived products (including immunoglobulin therapy) in the past 3 months, which might interfere with assessment of the immune response.
* 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 of the employees or the Investigator.

Primary outcomes:
measure: Geometric Mean Titers Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants
timeFrame: Day 28 post final vaccination
measure: Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants
timeFrame: Day 28 post final vaccination
measure: Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants
timeFrame: Day 28 post final vaccination
measure: Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months.
timeFrame: Day 28 post final vaccination
measure: Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years.
timeFrame: Day 28 post-vaccination
Secondary outcomes:
Other outcomes:
measure: Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants
timeFrame: Day 28 post final vaccination
measure: Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants
timeFrame: Day 28 post final vaccination
measure: Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants
timeFrame: Day 28 post final vaccination
measure: Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants.
timeFrame: Day 28 post final vaccination
measure: Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months.
timeFrame: Day 28 post final vaccination
measure: Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years.
timeFrame: Day 28 post-vaccination
measure: Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants
timeFrame: Day 28 post-vaccination
measure: Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants
timeFrame: Day 28 post final vaccination
measure: Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines.
timeFrame: Day 0 up to Day 7 post-vaccination
measure: Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines
timeFrame: Day 0 up to Day 7 post-vaccination
Locations:
city: Dothan
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Chandler
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Colorado Spring
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Ridgefield
country: United States
state: Connecticut
city: Boca Raton
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Miami Beach
country: United States
state: Florida
city: Ponte Vedra
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Arkansas City
country: United States
state: Kansas
city: Newton
country: United States
state: Kansas
city: Overland Park
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Bardstown
country: United States
state: Kentucky
city: Crestview Hills
country: United States
state: Kentucky
city: Lexington
country: United States
state: Kentucky
city: Metairie
country: United States
state: Louisiana
city: Columbia
country: United States
state: Maryland
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Binghamton
country: United States
state: New York
city: Cary
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburg
country: United States
state: Pennsylvania
city: Scranton
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Barnwell
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Clarksville
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Ft. Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Katy
country: United States
state: Texas
city: Layton
country: United States
state: Utah
city: Murray
country: United States
state: Utah
city: Orem
country: United States
state: Utah
city: Provo
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: South Jordan
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Midlothian
country: United States
state: Virginia
city: Williamsburg
country: United States
state: Virginia
city: Marshfield
country: United States
state: Wisconsin
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Greenberg DP, Robertson CA, Landolfi VA, Bhaumik A, Senders SD, Decker MD. Safety and immunogenicity of an inactivated quadrivalent influenza vaccine in children 6 months through 8 years of age. Pediatr Infect Dis J. 2014 Jun;33(6):630-6. doi: 10.1097/INF.0000000000000254.