Back to resultsSafety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
Primary Purpose
Prophylaxis: Influenza
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
TIVc_LOT A
TIVc_LOT B
TIVc_LOT C
TIVf
Sponsored by
About this trial
This is an interventional other trial for Prophylaxis: Influenza
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.
Sites / Locations
- Anaheim Clincial Trials
- Northern California Clinical Research Center
- Southern California CRC
- Broward Research Group
- Comprehensive Clinical Trials, LLC
- Palm Bech Research
- Meridian Clinical Research
- Johnson County Clin-Trials, LLC
- Heartland Research Associates, LLC
- Milford Emergency Associate,Inc
- Meridian Clinical Research
- Rochester Clinical Research, Inc
- PMG Research of Charlotte
- PMG Research of Hickory
- PMG Research of Raleigh
- New Horizons Clinical Research
- Columbia Research Group, Inc
- Omega Medical Research
- Clinical Research Solutions, LLC
- Clinical Research Associates, Inc
- Foothill Family Clinc South, J. Lewis Research Inc.
- Foothill Family Clinic, J. Lewis Research Inc.
- Jordan River Family Medicine, J. Lewis Research, Inc.
- Clinical Research Associates
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
TIVc-Lot A
TIVc-Lot B
TIVc-Lot C
TIVf
Arm Description
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
Outcomes
Primary Outcome Measures
Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.
Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay.
Secondary Outcome Measures
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.
Percentages of subjects achieving HI seroconversion after each of three vaccine strains were measured three weeks after vaccination of TIVc or TIVf vaccine (day 22).
Percentages of subjects who achieved HI titer ≥1:40 against each of three vaccine strains were measured three weeks after one vaccination of TIVc or TIVf vaccine.
HI assay analysis for TIVc vaccine was based on cell-based antigen and for TIVf vaccine was based on egg based antigen.
According to Center for Biologics Evaluation and Research recommendations (CBER 2007), CBER criteria are met when the lower limit of the 2-sided 95% CI for seroconversion/significant increase is ≥ 40%, and the lower limit of the 2-sided 95% CI for HI titers ≥ 1:40 is ≥ 70%.
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIVc and control vaccines.
Number of Subjects With Unsolicited Adverse Events
Safety was assessed as the number of subjects who reported Unsolicited Adverse Events after vaccination of TIVc and control vaccine.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02256488
Brief Title
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
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prophylaxis: Influenza
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1561 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TIVc-Lot A
Arm Type
Experimental
Arm Description
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
Arm Title
TIVc-Lot B
Arm Type
Experimental
Arm Description
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
Arm Title
TIVc-Lot C
Arm Type
Experimental
Arm Description
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
Arm Title
TIVf
Arm Type
Active Comparator
Arm Description
Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
Intervention Type
Biological
Intervention Name(s)
TIVc_LOT A
Intervention Description
Single IM (Intramuscular) administration dose of 0.5 mL of TIVc
Intervention Type
Biological
Intervention Name(s)
TIVc_LOT B
Intervention Description
Single IM administration dose of 0.5 mL of TIVc
Intervention Type
Biological
Intervention Name(s)
TIVc_LOT C
Intervention Description
Single IM administration dose of 0.5 mL of TIVc
Intervention Type
Biological
Intervention Name(s)
TIVf
Intervention Description
Single IM administration dose of 0.5 mL of TIVf
Primary Outcome Measure Information:
Title
Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.
Description
Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay.
Time Frame
Day 22
Secondary Outcome Measure Information:
Title
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.
Description
Percentages of subjects achieving HI seroconversion after each of three vaccine strains were measured three weeks after vaccination of TIVc or TIVf vaccine (day 22).
Percentages of subjects who achieved HI titer ≥1:40 against each of three vaccine strains were measured three weeks after one vaccination of TIVc or TIVf vaccine.
HI assay analysis for TIVc vaccine was based on cell-based antigen and for TIVf vaccine was based on egg based antigen.
According to Center for Biologics Evaluation and Research recommendations (CBER 2007), CBER criteria are met when the lower limit of the 2-sided 95% CI for seroconversion/significant increase is ≥ 40%, and the lower limit of the 2-sided 95% CI for HI titers ≥ 1:40 is ≥ 70%.
Time Frame
Day 22
Title
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
Description
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIVc and control vaccines.
Time Frame
Day 1 through day 7 (without 30 min)
Title
Number of Subjects With Unsolicited Adverse Events
Description
Safety was assessed as the number of subjects who reported Unsolicited Adverse Events after vaccination of TIVc and control vaccine.
Time Frame
Day 1 through day 22
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Anaheim Clincial Trials
City
Anaheim
State/Province
California
Country
United States
Facility Name
Northern California Clinical Research Center
City
Redding
State/Province
California
Country
United States
Facility Name
Southern California CRC
City
San Diego
State/Province
California
Country
United States
Facility Name
Broward Research Group
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
Comprehensive Clinical Trials, LLC
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Palm Bech Research
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Meridian Clinical Research
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
Johnson County Clin-Trials, LLC
City
Lenexa
State/Province
Kansas
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Milford Emergency Associate,Inc
City
Milford
State/Province
Massachusetts
Country
United States
Facility Name
Meridian Clinical Research
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Rochester Clinical Research, Inc
City
Rochester
State/Province
New York
Country
United States
Facility Name
PMG Research of Charlotte
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
PMG Research of Hickory
City
Hickory
State/Province
North Carolina
Country
United States
Facility Name
PMG Research of Raleigh
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
New Horizons Clinical Research
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Columbia Research Group, Inc
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
Country
United States
Facility Name
Clinical Research Solutions, LLC
City
Franklin
State/Province
Tennessee
Country
United States
Facility Name
Clinical Research Associates, Inc
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Foothill Family Clinc South, J. Lewis Research Inc.
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Foothill Family Clinic, J. Lewis Research Inc.
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Jordan River Family Medicine, J. Lewis Research, Inc.
City
South Jordan
State/Province
Utah
Country
United States
Facility Name
Clinical Research Associates
City
Norfolk
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
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