Clinical trial NCT02035696: Safety and Immunogenicity of a Four Influenza Vaccines in Children Ages 6 Months Old to Less Than 48 Months Old
Official title: A Phase I/II, Randomized, Observer-Blind, Multicenter Study to Evaluate Immunogenicity and Safety of Four Influenza Vaccines in Healthy Pediatric Subjects 6 to < 48 Months of Age.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza
Keywords: influenza
children
safety
tolerability
immunogenicity
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2014-01-14
Enrollment: 671
Sex: ALL
Minimum age (years): 6
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the safety and immunogenicity of four influenza vaccines in children 6 months to \< 48 months of age


Eligibility criteria: Inclusion Criteria:

* Healthy subject, male or female, 6 through \< 48 months of age at the time of enrollment, who has never previously received an influenza vaccine
* Individual who has a parent or guardian that can give written informed consent after understanding the nature of the study and are available for follow-up

Exclusion Criteria:

* Individuals recently vaccinated against influenza
* Subjects with contraindications to receive influenza vaccine

Primary outcomes:
measure: Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine
timeFrame: Day 50/Day 1
measure: Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine
timeFrame: Day 50 post vaccination
measure: Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine
timeFrame: Day 1 to Day 3
Secondary outcomes:
measure: Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine
timeFrame: Day 50 post vaccination
measure: Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine
timeFrame: Day 1, Day 50 post vaccination
measure: Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine
timeFrame: Day 50 post vaccination over day 1
measure: Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine
timeFrame: Day 50 post vaccination over day 1
measure: Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine
timeFrame: Day 1 and Day 50 post vaccination
measure: Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine
timeFrame: Day 1 and Day 50 post vaccination
measure: Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine
timeFrame: Day 1 and Day 50 post vaccination
measure: Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine
timeFrame: Day 1 to Day 7
measure: Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine
timeFrame: Unsolicited AEs after Each/any Vaccination from Day 1 to Day 29 and Day 29 to Day 50 , Day 1 to Day 209
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Site 116
state: Arizona
city: Tucson
country: United States
facility: Site 119
state: Arizona
city: Little Rock
country: United States
facility: Site 109
state: Arkansas
city: Long Beach
country: United States
facility: Site 112
state: California
city: Ontario
country: United States
facility: Site 113
state: California
city: San Diego
country: United States
facility: Site 117
state: California
city: West Covina
country: United States
facility: Site 114
state: California
city: Thornton
country: United States
facility: Site 107
state: Colorado
city: Miami Beach
country: United States
facility: Site 108
state: Florida
city: Miami
country: United States
facility: Site 111
state: Florida
city: Gainesville
country: United States
facility: Site 121
state: Georgia
city: Omaha
country: United States
facility: Site 101
state: Nebraska
city: Omaha
country: United States
facility: Site 104
state: Nebraska
city: Omaha
country: United States
facility: Site 105
state: Nebraska
city: Omaha
country: United States
facility: Site 106
state: Nebraska
city: Youngstown
country: United States
facility: Site 103
state: Ohio
city: Charleston
country: United States
facility: Site 102
state: South Carolina
city: Houston
country: United States
facility: Site 115
state: Texas
city: Saint George
country: United States
facility: Site 118
state: Utah
city: Salt Lake City
country: United States
facility: Site 110
state: Utah
city: Spokane
country: United States
facility: Site 120
state: Washington
city: Kuopio
country: Finland
facility: Site 502
city: Tampere
country: Finland
facility: Site 506
city: Manila
country: Philippines
facility: Site 301
city: Muntinlupa
country: Philippines
facility: Site 302
city: Bangkok
country: Thailand
facility: Site 201
city: Bangkok
country: Thailand
facility: Site 202
Study officials:
References: