Clinical trial NCT02256488: Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
Official title: A Phase III, Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prophylaxis: Influenza
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-10-03
Enrollment: 1561
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the immunologic equivalence of three consecutive lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit influenza vaccine (TIVf).

The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws. Female subjects of childbearing potential were tested for pregnancy before the administration of the vaccine and included only if using and agreeing to continue to use contraception during the course of the study.

The total study participation time per subject is about 3 weeks.


Eligibility criteria: Inclusion Criteria:

* Males or females 18 through 49 years of age.
* Subjects having provided informed consent.
* Individuals in good health

Exclusion Criteria:

* Chronic or acute illness that would interfere with the subject's safety and/or could interfere with the evaluation of study vaccine, including known history of anaphylaxis, serious vaccine reactions or hypersensitivity, known immunodeficiency or receiving immunosuppressive therapy.
* Female of childbearing potential not using acceptable contraceptive methods, pregnant or breastfeeding.

Primary outcomes:
measure: Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.
timeFrame: Day 22
Secondary outcomes:
measure: Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine.
timeFrame: Day 22
measure: Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
timeFrame: Day 1 through day 7 (without 30 min)
measure: Number of Subjects With Unsolicited Adverse Events
timeFrame: Day 1 through day 22
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clincial Trials
state: California
city: Redding
country: United States
facility: Northern California Clinical Research Center
state: California
city: San Diego
country: United States
facility: Southern California CRC
state: California
city: Hollywood
country: United States
facility: Broward Research Group
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Palm Bech Research
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Lenexa
country: United States
facility: Johnson County Clin-Trials, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Milford
country: United States
facility: Milford Emergency Associate,Inc
state: Massachusetts
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc
state: New York
city: Charlotte
country: United States
facility: PMG Research of Charlotte
state: North Carolina
city: Hickory
country: United States
facility: PMG Research of Hickory
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research of Raleigh
state: North Carolina
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Portland
country: United States
facility: Columbia Research Group, Inc
state: Oregon
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Franklin
country: United States
facility: Clinical Research Solutions, LLC
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc
state: Tennessee
city: Salt Lake City
country: United States
facility: Foothill Family Clinc South, J. Lewis Research Inc.
state: Utah
city: Salt Lake City
country: United States
facility: Foothill Family Clinic, J. Lewis Research Inc.
state: Utah
city: South Jordan
country: United States
facility: Jordan River Family Medicine, J. Lewis Research, Inc.
state: Utah
city: Norfolk
country: United States
facility: Clinical Research Associates
state: Virginia
Study officials:
References: