Clinical trial NCT01992094: Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older
Official title: A Phase III, Stratified, Randomized, Double-Blind, Multicenter, NonInferiority Study to Evaluate the Safety and Immunogenicity of a Cell-based Quadrivalent Subunit Influenza Virus Vaccine and Cell-based Trivalent Subunit Influenza Virus Vaccines in Adults Ages ≥18 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Influenza vaccine
Novartis
Adults
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 2680
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate safety and immunogenicity of three influenza vaccines in adults 18 years of age and above.


Eligibility criteria: Inclusion Criteria:

1. Male or female ages 18 years and older.
2. Individuals who give written informed consent, who can comply with study procedures, and who are available for follow-up.

Exclusion Criteria:

1. Individuals recently vaccinated against influenza
2. Subjects with contraindications to receive influenza vaccine
3. Please contact the site for additional eligibility criteria

Primary outcomes:
measure: 1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c
timeFrame: Three weeks post vaccination (Day 22)
measure: 2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c
timeFrame: Three weeks post vaccination (Day 22)
Secondary outcomes:
measure: 3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts
timeFrame: Three weeks post vaccination (Day 22)
measure: 4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts
timeFrame: Three weeks post vaccination (Day 22)
measure: 5.Geometric Mean Ratios (GMR) in Subjects After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
timeFrame: Three weeks post vaccination (Day 22)
measure: 6. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
timeFrame: Three weeks post vaccination (Day 22)
measure: 7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts
timeFrame: Three weeks post vaccination (Day 22)
measure: 8.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c Against B2 Strain
timeFrame: Three weeks post vaccination (Day 22)
measure: 9.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c Against B2 Strain
timeFrame: Three weeks post vaccination (Day 22)
measure: 10.GMT in Subjects After Receiving One Dose of Either QIVc, TIV2c Against B1 Strain
timeFrame: Three weeks post vaccination (Day 22)
measure: 11.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV2c Against B1 Strain
timeFrame: Three weeks post vaccination (Day 22)
measure: 12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
timeFrame: Day 1 to 7 post vaccination
measure: 13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group
timeFrame: Day 1 to 181 post vaccination
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: San Diego
country: United States
state: California
city: Coral Gables
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Peoria
country: United States
state: Illinois
city: Mishawaka
country: United States
state: Indiana
city: Council Bluffs
country: United States
state: Iowa
city: Newton
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Metairie
country: United States
state: Louisiana
city: Rockville
country: United States
state: Maryland
city: Edina
country: United States
state: Minnesota
city: Bellevue
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Endwell
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Cary
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Warwick
country: United States
state: Rhode Island
city: Anderson
country: United States
state: South Carolina
city: Mt. Pleasant
country: United States
state: South Carolina
city: Dakota Dunes
country: United States
state: South Dakota
city: Austin
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: San Angelo
country: United States
state: Texas
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
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References: