Clinical trial NCT02255409: Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine (QIV) in Children Previously Vaccinated in Trial V118_05
Official title: A Phase III, Randomized, Observer Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Repeated Exposure to an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV), Administered to Subjects Previously Vaccinated in Trial V118_05
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2014-10-02
Enrollment: 607
Sex: ALL
Minimum age (years): 12
Maximum age (years): 84
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously Vaccinated in Trial V118_05


Eligibility criteria: Inclusion Criteria:

1. Male or female subject who has completed their Day 181 clinic visit for non-naïve subjects or their Day 209 clinic visit for naïve subjects in parent study.
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: Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs.
timeFrame: Day 1 through Day 356
measure: Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 22)
timeFrame: Day 1, Day 22
measure: Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and and Differences in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 22).
timeFrame: Day 1, Day 22
Secondary outcomes:
measure: Safety Endpoint: Number of Subjects With a Diagnosis of Failure to Thrive or Short Stature
timeFrame: Day 1 through Day 366 (Day 1, Day 22, Day 181, Day 366)
measure: Safety Endpoint: Number of Subjects With Any Unsolicited AEs
timeFrame: Day 1 through Day 22
measure: Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)
timeFrame: Up to 7 days following vaccination
measure: Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 181)
timeFrame: Day 1, Day 181
measure: Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 181)
timeFrame: Day 1, Day 181
measure: Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181)
timeFrame: Day 1, Day 22, Day 181
measure: Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains
timeFrame: Day 1, Day 22, and Day 181
measure: Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Difference in Percentage of Subjects Achieving Seroconversion for Heterologous Influenza Strains (Day 181)
timeFrame: Day 1, Day 181
measure: Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Heterologous Influenza Strains (Day 181)
timeFrame: Day 1, Day 181
measure: Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181)
timeFrame: Day 1, Day 22, Day 181
measure: Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains
timeFrame: Day 1, Day 22, and Day 181
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
city: San Gabriel
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Melbourne
country: United States
state: Florida
city: Augusta
country: United States
state: Kansas
city: Newton
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Metairie
country: United States
state: Louisiana
city: Bellevue
country: United States
state: Nebraska
city: Binghamton
country: United States
state: New York
city: Dayton
country: United States
state: Ohio
city: Austin
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: San Angelo
country: United States
state: Texas
city: Tomball
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: West Jordan
country: United States
state: Utah
city: Espoo
country: Finland
city: Helsinki
country: Finland
city: Helsinki
country: Finland
city: Järvenpää
country: Finland
city: Kokkola
country: Finland
city: Pori
country: Finland
city: Tampere
country: Finland
city: Turku
country: Finland
city: Vantaa
country: Finland
Study officials:
References: