Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
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
1 other identifier
interventional
1,561
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2014
Shorter than P25 for phase_3
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 26, 2014
CompletedFirst Posted
Study publicly available on registry
October 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
August 7, 2015
CompletedJune 11, 2019
May 1, 2019
3 months
September 26, 2014
July 10, 2015
May 28, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Day 22
Secondary Outcomes (3)
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.
Day 22
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
Day 1 through day 7 (without 30 min)
Number of Subjects With Unsolicited Adverse Events
Day 1 through day 22
Study Arms (4)
TIVc-Lot A
EXPERIMENTALSubjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
TIVc-Lot B
EXPERIMENTALSubjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
TIVc-Lot C
EXPERIMENTALSubjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
TIVf
ACTIVE COMPARATORSubjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
Interventions
Eligibility Criteria
You may qualify if:
- Males or females 18 through 49 years of age.
- Subjects having provided informed consent.
- Individuals in good health
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Anaheim Clincial Trials
Anaheim, California, United States
Northern California Clinical Research Center
Redding, California, United States
Southern California CRC
San Diego, California, United States
Broward Research Group
Hollywood, Florida, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, United States
Palm Bech Research
West Palm Beach, Florida, United States
Meridian Clinical Research
Savannah, Georgia, United States
Johnson County Clin-Trials, LLC
Lenexa, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Milford Emergency Associate,Inc
Milford, Massachusetts, United States
Meridian Clinical Research
Omaha, Nebraska, United States
Rochester Clinical Research, Inc
Rochester, New York, United States
PMG Research of Charlotte
Charlotte, North Carolina, United States
PMG Research of Hickory
Hickory, North Carolina, United States
PMG Research of Raleigh
Raleigh, North Carolina, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
Columbia Research Group, Inc
Portland, Oregon, United States
Omega Medical Research
Warwick, Rhode Island, United States
Clinical Research Solutions, LLC
Franklin, Tennessee, United States
Clinical Research Associates, Inc
Nashville, Tennessee, United States
Foothill Family Clinc South, J. Lewis Research Inc.
Salt Lake City, Utah, United States
Foothill Family Clinic, J. Lewis Research Inc.
Salt Lake City, Utah, United States
Jordan River Family Medicine, J. Lewis Research, Inc.
South Jordan, Utah, United States
Clinical Research Associates
Norfolk, Virginia, United States
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2014
First Posted
October 3, 2014
Study Start
September 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
June 11, 2019
Results First Posted
August 7, 2015
Record last verified: 2019-05