Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
NCT ID: NCT02256488
Last Updated: 2019-06-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1561 participants
INTERVENTIONAL
2014-09-30
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older
NCT01992094
Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects
NCT00845429
Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age
NCT01857206
A Study to Evaluate the Safety of Two Influenza Vaccines in Children and Adolescents 3 to <18 Years of Age at Risk for Influenza-Related Complications
NCT01998477
Safety and Immunogenicity of Three Influenza Vaccines in Children Aged 4 Years Old to Less Than 18 Years Old
NCT01992107
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TIVc-Lot A
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
TIVc_LOT A
Single IM (Intramuscular) administration dose of 0.5 mL of TIVc
TIVc-Lot B
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
TIVc_LOT B
Single IM administration dose of 0.5 mL of TIVc
TIVc-Lot C
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
TIVc_LOT C
Single IM administration dose of 0.5 mL of TIVc
TIVf
Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
TIVf
Single IM administration dose of 0.5 mL of TIVf
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TIVc_LOT A
Single IM (Intramuscular) administration dose of 0.5 mL of TIVc
TIVc_LOT B
Single IM administration dose of 0.5 mL of TIVc
TIVc_LOT C
Single IM administration dose of 0.5 mL of TIVc
TIVf
Single IM administration dose of 0.5 mL of TIVf
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects having provided informed consent.
* Individuals in good health
Exclusion Criteria
* Female of childbearing potential not using acceptable contraceptive methods, pregnant or breastfeeding.
18 Years
49 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Vaccines
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
V58_23
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.