Prophylaxis: Influenza Clinical Trial
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
| NCT number | NCT02256488 |
| Other study ID # | V58_23 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | September 2014 |
| Est. completion date | December 2014 |
| Verified date | May 2019 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1561 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 49 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Anaheim Clincial Trials | Anaheim | California |
| United States | PMG Research of Charlotte | Charlotte | North Carolina |
| United States | New Horizons Clinical Research | Cincinnati | Ohio |
| United States | Clinical Research Solutions, LLC | Franklin | Tennessee |
| United States | PMG Research of Hickory | Hickory | North Carolina |
| United States | Broward Research Group | Hollywood | Florida |
| United States | Johnson County Clin-Trials, LLC | Lenexa | Kansas |
| United States | Milford Emergency Associate,Inc | Milford | Massachusetts |
| United States | Clinical Research Associates, Inc | Nashville | Tennessee |
| United States | Clinical Research Associates | Norfolk | Virginia |
| United States | Meridian Clinical Research | Omaha | Nebraska |
| United States | Columbia Research Group, Inc | Portland | Oregon |
| United States | PMG Research of Raleigh | Raleigh | North Carolina |
| United States | Northern California Clinical Research Center | Redding | California |
| United States | Rochester Clinical Research, Inc | Rochester | New York |
| 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 | Southern California CRC | San Diego | California |
| United States | Meridian Clinical Research | Savannah | Georgia |
| United States | Jordan River Family Medicine, J. Lewis Research, Inc. | South Jordan | Utah |
| United States | Omega Medical Research | Warwick | Rhode Island |
| United States | Comprehensive Clinical Trials, LLC | West Palm Beach | Florida |
| United States | Palm Bech Research | West Palm Beach | Florida |
| United States | Heartland Research Associates, LLC | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Vaccines |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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%. |
Day 22 | |
| Secondary | 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. | Day 1 through day 7 (without 30 min) | |
| Secondary | 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. | Day 1 through day 22 |